What to Do When a Medical Device Is Involved in an Incident

A practical guide for biomeds when equipment may have been involved in patient harm, injury, or an unexpected clinical event

Most biomed work orders are routine.

Published August 12, 2026 · Revised September 6, 2026

Back to Biomed Basics

What This Page Explains

This page covers:

The exact process at your facility may be different.

Always follow your organization's incident-management, risk-management, clinical engineering, safety, and reporting procedures.

The Simple Version

When equipment may be connected to patient harm or a serious clinical event, do not begin routine repair. Remove it from normal use according to facility policy, protect the device and associated accessories, and notify the required clinical, risk, safety, regulatory, or leadership contacts. You may have only one opportunity to preserve its post-event condition.

  1. Make sure the device is removed from normal clinical use.
  2. Follow your facility's incident process.
  3. Preserve the device and everything associated with it.
  4. Avoid changing settings, logs, configuration, or software.
  5. Document the condition in which you received it.
  6. Escalate appropriately.
  7. Troubleshoot only after you are authorized to proceed.

Photograph and document the condition received, including connections, consumables, settings, displayed time, damage, labels, and custody. Avoid unnecessary power cycles, resets, updates, charging, cleaning, or log access until authorized because ordinary actions can overwrite volatile evidence. Troubleshooting begins only after the responsible incident process defines what may be changed.

This Is Not a Normal Work Order

Imagine an infusion pump comes into the shop because:

Battery does not hold a charge.

You probably begin troubleshooting immediately.

Now imagine the complaint is:

Patient received an unexpected infusion and this was the pump being used.

Completely different situation.

You do not want to immediately:

Any of those actions could change information that helps explain what happened.

Patient Care Comes First

Biomed's role usually begins after immediate clinical care has been addressed.

If an incident is actively occurring, clinical staff should follow the appropriate patient-care and emergency procedures.

Do not interfere with urgent clinical care because you want to preserve equipment evidence.

Once the situation is stabilized, the equipment can be secured and evaluated according to facility procedure.

Remove the Device From Normal Use

If the equipment may have been involved in a serious event, it generally should not simply return to normal circulation while the event is being evaluated.

Follow your facility's process for:

You want to prevent someone from seeing the device sitting nearby and putting it back into use.

Do Not Immediately Power-Cycle It

Biomeds love power cycles.

And for routine troubleshooting, there is nothing wrong with that.

After a serious incident, think first.

Power cycling may:

If the device is safe to leave in its current state, document the current state before changing it.

Do Not Automatically Turn It Off Either

This sounds contradictory.

Sometimes leaving a device powered may preserve information.

Other times, safely powering it down may be necessary.

The correct action depends on:

The important point is:

Do not make an automatic habit out of immediately turning everything off or rebooting everything.

Think about what information may be lost.

Look Before You Touch

When you first see the device, observe it.

What is on the display?

Are any alarms active?

What mode is it in?

What settings are displayed?

Is it on AC or battery?

What accessories are attached?

Are cables connected?

Is there visible damage?

Is there fluid present?

Are doors, covers, clamps, valves, or cartridges in a particular position?

Before changing anything, document the condition.

Take Photographs When Allowed

Photographs can preserve details that are easy to forget.

Depending on facility policy, useful photographs may include:

Be extremely careful with patient information.

Follow facility privacy and incident-documentation policies.

Do not casually take pictures on a personal phone if that is not allowed.

Record the Exact Device

Capture:

Do not assume the asset number alone is enough.

The serial number identifies the actual device.

Preserve the Accessories

This is extremely important.

The main device may not be the cause.

The problem may involve:

Do not separate everything and throw the accessories into normal circulation.

If your facility procedure calls for preserving associated components, keep the original setup together and identify what was connected.

Disposable Components Can Matter

A disposable accessory may contain important evidence.

For example:

Do not automatically throw these away because they are normally disposable.

Follow the incident procedure for handling anything potentially relevant.

Clinical, infection-control, laboratory, risk, manufacturer, or other requirements may also affect how items are preserved and handled.

Preserve the Setup

Imagine an infusion pump incident.

If someone immediately:

you may have lost important information.

Instead, when safe and permitted, document:

The same principle applies to other equipment.

Ventilator Example

Suppose a ventilator was involved in an unexpected loss of ventilation.

Before dismantling the circuit, document:

The eventual problem might be:

Preserve the information before deciding.

Patient Monitor Example

A patient monitor allegedly failed to alarm.

Do not start by changing the alarm limits.

Document:

Later you can test whether the alarm behaves correctly.

First preserve how it was configured.

Infusion Pump Example

A pump was involved in a possible over-infusion.

Do not immediately run a calibration.

First document what you can about:

Calibration comes later.

Defibrillator Example

A defibrillator allegedly failed during a resuscitation.

Preserve:

Do not simply connect it to the analyzer and start firing shocks before the event information has been secured.

Do Not Clear Error Messages

The error message may be one of the strongest clues you have.

Record:

If possible under your procedure, photograph it.

Do not rely on:

It said something about a battery.

Exact information matters.

Do Not Clear Logs

Many devices maintain:

Those logs may help reconstruct what happened.

Do not clear them before they have been reviewed and preserved.

Do Not Change the Clock

Timestamps can be extremely important during an investigation.

If the device clock is wrong:

Document that it is wrong.

Example:

Device displayed 14:32. Actual time approximately 14:39.

Do not immediately correct it.

The clock difference itself may be important when comparing device logs to:

Time Synchronization Matters

A hospital event may involve multiple systems.

For example:

13:41:05 — Monitor alarm.

13:41:12 — Nurse call event.

13:41:20 — Ventilator alarm.

13:41:50 — Staff documentation.

If one device clock is seven minutes slow, the timeline can look completely wrong until that offset is understood.

Document time differences before correcting them.

Preserve the Battery

If the incident involved:

the original battery may be extremely important.

Do not immediately swap it with a known-good battery and lose track of which one was installed.

Record:

Later, battery testing may be part of the investigation.

Preserve the Power Cord and Adapter

If the event involved power:

Keep track of:

The device itself may be fine.

The power source may be the problem.

Do Not Update Software

This should be obvious, but it is worth stating.

Do not perform a software update on a device involved in an unresolved serious incident unless the approved investigation process specifically calls for it.

An update may:

Preserve first.

Modify later.

Do Not Perform Factory Resets

A factory reset is especially destructive to evidence.

It may remove:

Do not factory reset the device during initial incident handling.

Do Not Start Replacing Parts

You find a loose connector.

It is tempting to reseat it immediately.

Do not rush.

Document it first.

A disconnected cable may be the reason the event happened.

If you reconnect it before documenting the finding, you have changed the evidence.

Photograph or document the condition according to your procedure before correcting anything.

Separate Observation From Diagnosis

This is extremely important.

Write:

Power cord connector found approximately halfway inserted into device inlet.

Do not immediately write:

Loose power cord caused patient incident.

The first statement is an observation.

The second is a conclusion.

You may not have enough information to make that conclusion.

Facts vs Assumptions

Good incident documentation might say:

Unit received powered on with battery indication 43%. AC power cord was disconnected. Screen displayed “Battery Low” alarm. No visible enclosure damage noted.

That is factual.

Weak documentation:

Nurse must have unplugged it and drained the battery.

That is speculation.

Stick to what you know.

Do Not Assign Blame

Biomed's role is technical investigation.

Avoid statements like:

unless the investigation has actually established that conclusion and you are responsible for making it.

Early assumptions can steer the investigation in the wrong direction.

Interviewing Clinical Staff

If your role includes gathering information, ask neutral questions.

Instead of:

Did you accidentally unplug it?

Ask:

Was the device connected to AC power when the event occurred?

Instead of:

Did you program the pump wrong?

Ask:

Do you remember what rate and mode were displayed?

You are collecting information.

Not conducting an interrogation.

Useful Questions

Ask:

These details help reconstruct the event.

Build a Timeline

A timeline can be extremely useful.

For example:

10:12 — Patient transport begins.

10:19 — Monitor displays battery warning.

10:22 — Monitor reportedly shuts down.

10:24 — Staff reconnect AC.

10:25 — Monitor restarts.

Then compare that timeline with:

You may begin to see what happened.

Escalate Early

Serious incidents should not become one technician quietly troubleshooting in the back of the shop.

Follow your facility process.

Depending on the event, that may involve:

Your job may be one piece of a much larger investigation.

Manufacturer Involvement

The manufacturer may be able to:

If the manufacturer will evaluate the device, follow your organization's instructions before shipping anything.

Make sure the device and associated items are properly identified and tracked.

Chain of Custody

For particularly serious events, your organization may have formal procedures controlling:

Follow those procedures.

Do not casually loan the device to someone or send it away without documentation.

When Can Troubleshooting Begin?

Once the appropriate people authorize technical evaluation, troubleshooting can begin in a controlled way.

That might include:

Document each action.

The investigation should be reproducible.

Change One Thing at a Time

This matters even more after an incident.

If you immediately:

and the problem disappears, you have destroyed much of your ability to determine what fixed it.

Controlled troubleshooting preserves information.

Document Test Conditions

Record:

If someone later asks:

How did you determine the pump was accurate?

you should be able to explain exactly what you tested.

Passing Tests Do Not Prove the Incident Did Not Happen

This is an important concept.

Suppose a ventilator involved in an incident passes every test afterward.

That tells you:

The ventilator passed those tests when you performed them.

It does not automatically prove:

The ventilator could not have malfunctioned earlier.

Intermittent problems exist.

Environmental conditions change.

Accessories change.

Software states change.

Document the passing result accurately without overstating it.

Failure Does Not Automatically Prove Causation Either

The opposite is also true.

You discover the battery has poor capacity.

That does not automatically prove:

The battery caused the clinical outcome.

It may be relevant.

It may not.

Your technical findings are pieces of evidence.

Causation may require a broader investigation.

Common Mistakes

Immediately Starting the Repair

Preserve the evidence first.

Rebooting the Device Automatically

You may alter information.

Throwing Away Disposables

They may matter.

Separating Accessories

Preserve the original setup when required.

Clearing Logs

Never do this casually after an incident.

Correcting the Device Clock

Document the offset first.

Writing Conclusions Instead of Observations

Stick to facts.

Assigning Blame

That is not the goal.

Returning the Device to Service Too Quickly

Complete the required investigation and verification.

A Useful First Question

When you receive equipment after a serious event, ask:

What could I accidentally change right now that we may want to know later?

That question changes your mindset.

Do not rush.

Observe.

Preserve.

Document.

Then investigate.

What Did You Actually Prove?

This question becomes even more important during incident investigation.

If the device passes functional testing, say:

Device passed functional testing.

Do not automatically say:

Device did not contribute to the event.

Those are not the same conclusion.

If the battery fails capacity testing, say:

Battery capacity measured below required specification.

Do not automatically say:

Battery caused the event.

Let the evidence build the story.

Final Thoughts for Biomeds

Serious equipment incidents are different from ordinary repairs.

Your normal instinct is:

Find the problem and fix it.

In an incident, the order changes.

First:

Preserve.

Then:

Document.

Then:

Understand.

Then:

Test.

Then, when appropriate:

Repair.

You may get only one opportunity to see the medical device exactly as it existed after the event.

Treat that moment carefully.

Preserve the equipment.

Preserve the accessories.

Preserve the settings.

Preserve the logs.

Record what you actually observe.

Avoid assumptions.

And involve the appropriate people early.

A good biomed does more than repair equipment after something goes wrong.

Sometimes your most important job is making sure the evidence needed to understand what happened is still there.

— Jake

Important Note

This page is an educational overview and is not a substitute for your healthcare organization's incident-response, risk-management, regulatory-reporting, legal, patient-safety, privacy, or evidence-preservation procedures. Serious events involving medical devices may trigger internal and external reporting requirements. Follow your facility's established process and involve the appropriate leadership before altering, testing, repairing, releasing, or shipping involved equipment.

Related Biomed Basics

Back to Biomed Basics