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Asset Type
Extracorporeal Membrane Oxygenation (ECMO) System
Manufacturer
Model
What This Guide Helps With
Troubleshoots blank or abnormal display, unresponsive controls, and absent alarm audio involving power, connections, settings, damage, and environmental causes.
Step-by-Step Troubleshooting
1. Protect the Patient and Replace Unreliable User-Interface Equipment
A ROTAFLOW II with unreliable display, speed control, or alarm audio should not remain responsible for patient support when those functions cannot be trusted.
Coordinate transfer to verified backup equipment according to the ECMO team's contingency procedure.
Expected outcome: Patient support and alarm surveillance do not depend on an unreliable interface.
2. Confirm Which Function Has Failed
Determine whether the problem affects:
- Entire display
- Portions of the display
- Control knob rotation
- Control knob selection or confirmation
- One or more buttons
- Alarm audio
- Alarm visual indication
- Multiple interface functions together
Record any intermittent behavior and displayed messages.
Expected outcome: The fault is isolated to a specific interface or alarm function.
3. Verify Console Power and Startup
Confirm the system has stable power and completes startup normally. A broader power problem can appear as a display or control failure.
Expected outcome: The console remains powered and stable. If power correction restores the interface, proceed to verification.
4. Inspect the External User Interface
Look for:
- Cracked display
- Loose control knob
- Sticking controls
- Fluid contamination
- Cleaning residue
- Impact damage
- Heat damage
- Physical obstruction around controls
Do not operate equipment with a cracked enclosure, evidence of fluid intrusion, or damaged controls that could cause unpredictable operation.
Expected outcome: The interface is clean, dry, unobstructed, and physically intact.
5. Verify Normal User Settings
Check normal accessible settings relevant to display visibility or alarm presentation without changing protected clinical configuration.
Do not reduce, bypass, or disable required alarm functions in order to make the system appear operational.
Expected outcome: The complaint is not caused by an ordinary user-accessible setting.
6. Check Alarm Audio in an Approved Test
With the system safely off the patient, perform the normal alarm verification applicable to the equipment.
Confirm both audible and visual indications where required.
Expected outcome: Alarm audio is clearly present and corresponding visual indications operate normally. If audio remains absent, the device should not return to clinical use.
7. Exercise the Control Knob and Accessible Controls
On a safe test setup, operate the control knob and front-panel controls through normal user functions.
Look for:
- Missed inputs
- Double inputs
- Erratic value changes
- Inability to confirm a selection
- Physical looseness or binding
Expected outcome: Each control produces a predictable single response.
8. Perform a Controlled Restart
If no physical damage is present and external causes have been excluded, perform one controlled restart.
Do not rely on repeated restarting to manage an intermittent user-interface or alarm failure.
Expected outcome: Display, controls, and alarm functions initialize and remain stable after startup.
9. Perform Final Functional Verification
Verify:
- Display remains readable and stable
- Controls respond predictably
- Pump commands can be entered appropriately on a test setup
- Audible alarms function
- Visual alarms function
- No spontaneous resets or interface freezes occur
Expected outcome: User interface and alarm functions are reliable. Troubleshooting can stop after all return-to-service requirements pass.
10. Escalate an Unresolved Interface or Alarm Failure
If the display remains abnormal, controls remain unreliable, or alarm audio cannot be verified, remove the device from service.
Expected outcome: The unit is withheld from patient use until qualified repair restores reliable control and alarm functions.
If the Problem Persists
External power, settings, contamination, physical obstruction, and controlled restart have been ruled out. Persistent problems may involve the display assembly, controls, alarm hardware, internal communication, software, or system electronics.
The device should be:
- Removed from service
- Labeled Out of Service
- Sent for repair or bench evaluation
- Evaluated using appropriate Getinge documentation and approved test equipment
- Repaired or configured only by qualified personnel
Do not return an ECMO system to service with unreliable controls or alarm annunciation. Complete full functional and alarm verification following repair.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
A functioning pump is not enough for safe ECMO support; clinicians must also have reliable controls, displayed information, and audible alarm notification.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"ECMO staff reported the ROTAFLOW II alarm could be seen on the display but could not be heard during equipment setup."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering confirmed alarm audio remained absent during approved testing despite normal power and user-accessible settings."
Resolution
What action was taken.
Example:
"Removed the console from service, labeled it Out of Service, and sent it for qualified repair because reliable alarm audio could not be verified."
Helpful Details to Include (If Known)
- Exact failed interface function
- Display condition
- Control knob behavior
- Alarm audio behavior
- Visual alarm behavior
- AC or battery operation
- Evidence of fluid or physical damage
- Settings observed
- Controlled restart result
- Approved alarm test result
- Final device status
Final Thought
Protect the patient from unreliable controls or alarms, rule out power, settings, contamination, and external damage first, verify every corrected function, and remove the system from service when reliability remains uncertain.
That is successful troubleshooting.