Stryker LIFEPAK 35

Pacing failure / no capture concern

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Asset Type

Defibrillator

Manufacturer

Stryker

Model

LIFEPAK 35

What This Guide Helps With

Troubleshooting reported pacing failure, absent pacing output, or suspected non-capture while separating patient-related concerns from device, electrode, cable, or setup issues.

Step-by-Step Troubleshooting

Ensure Patient Safety First

Do not troubleshoot suspected pacing failure while the LIFEPAK 35 is being relied upon for active patient therapy.

If pacing is required and capture is absent or uncertain:

Expected: Patient care continues with a known-good device.

Why it matters: The LIFEPAK 35 is intended to provide non-invasive pacing, but apparent “no capture” does not by itself prove device failure. Stryker identifies non-invasive pacing as a therapy function of the LIFEPAK 35.

Clarify What “Pacing Failure” Actually Means

Interview the reporting clinician and determine whether the complaint was:

Review available event information and device logs when accessible.

Expected: The complaint is narrowed to a reproducible device-function concern rather than the broad statement “pacer failed.”

Why it matters: A patient who does not achieve capture is not automatically evidence of defective pacing output.

Inspect the Device for Obvious External Damage

With the unit removed from patient use, inspect:

Do not use damaged, expired, opened, dried, or questionable therapy electrodes for evaluation.

Expected: Therapy-path components are physically intact and suitable for testing.

If damage is found: Replace the affected approved accessory and retest. If the issue resolves, document the finding and stop.

Verify Therapy Cable and Electrode Compatibility

Confirm that the connected therapy cable and disposable therapy electrodes are approved and appropriate for the LIFEPAK 35 configuration being evaluated.

Check that:

Expected: A complete and secure external therapy path is established.

If reseating or replacing the external accessory resolves the issue: Complete verification testing, document the corrective action, and stop.

Rule Out a Single Defective Electrode Set

When safe and consistent with department procedure, replace the suspect electrode set with a known-good compatible set for bench evaluation.

Do not assume the defibrillator is defective based on one set of disposable electrodes.

Expected: The complaint either clears with replacement electrodes or remains present with known-good accessories.

If the issue clears: The original electrode set or connection was the likely cause. Stop after required verification.

Rule Out a Therapy Cable Problem

If the concern persists, repeat the controlled evaluation using a known-good compatible therapy cable when available.

Pay particular attention to intermittent behavior caused by:

Expected: Pacing behavior remains stable with a known-good cable.

If the problem follows the original cable: Remove that cable from service, replace it, perform required verification, and stop.

Verify Pacing Mode Setup and Observable Device Response

Using an appropriate simulator or defibrillator analyzer rather than a patient, verify that the LIFEPAK 35:

The LIFEPAK 35 supports manual mode for noninvasive pacing, and Stryker documentation describes on-screen pacing guidance.

Expected: Pacing controls respond normally and the device behaves consistently as settings are changed.

If controls do not respond or pacing mode behaves abnormally: Stop routine troubleshooting and escalate for service evaluation.

Test Pacing Output With an Appropriate Defibrillator Analyzer

Connect the LIFEPAK 35 to a compatible calibrated defibrillator analyzer using the correct approved test setup.

Verify pacing performance according to your organization’s approved inspection procedure, including applicable checks for:

Stryker publishes a LIFEPAK 35 Performance Inspection Procedure specifically supporting controlled performance verification, and its official service documentation addresses maintenance and testing.

Expected: Measured pacing performance meets the applicable manufacturer procedure and local acceptance criteria.

If measured output is normal: Do not conclude that the defibrillator failed solely because clinical capture was absent.

If output is missing, intermittent, or outside acceptance criteria: Remove the device from service and escalate for repair.

Attempt to Reproduce the Reported Failure Under Controlled Conditions

If initial analyzer testing passes, repeat controlled checks while observing for:

Do not perform destructive testing or open the unit solely to chase an intermittent complaint.

Expected: The unit remains stable through repeated controlled checks.

If the failure recurs: Capture the exact behavior, remove the unit from service, and escalate.

Review Device Logs and Reported Error Information

Review available service or event information for faults occurring near the reported incident.

Document:

Expected: No unresolved therapy-related fault remains unexplained.

If a pacing or therapy-related fault is active or recurring: Escalate using the applicable Stryker service information rather than clearing the device for use based only on a successful power cycle.

Perform the Applicable Post-Service Performance Verification

After replacing an external accessory or completing authorized service, perform the required functional and performance verification before return to use.

At minimum, confirm applicable:

Use your approved procedure and the applicable Stryker LIFEPAK 35 performance inspection requirements.

Expected: The device passes all required acceptance checks without recurrence.

If the device passes and the cause was corrected: Return to service according to department policy and stop.

If the Problem Persists

If known-good electrodes, therapy cables, secure connections, correct setup, and controlled analyzer testing do not resolve the concern, common external causes have been ruled out and an internal therapy-system fault is more likely.

The device should be:

Escalate for qualified evaluation using the applicable Stryker service procedure. Do not proceed into internal therapy circuitry, high-voltage assemblies, or board-level repair unless specifically trained and authorized.

Knowing when to stop is proper troubleshooting. The LIFEPAK 35 has manufacturer-specific service and performance inspection documentation for qualified technical evaluation.

Clinical Use Tip

Never equate electrical pacing activity with confirmed patient capture. Clinical staff must assess capture using appropriate clinical methods and patient response. Clinical Engineering should verify device output with proper test equipment, not by troubleshooting on an active patient.

Do not troubleshoot on an active patient. Move the patient to a backup device first and maintain therapy continuity.

Work Order Documentation (CCR Method)

CCR = Complaint, Cause, Resolution

Complaint

What was reported by the clinical staff.

Example:
"Clinical staff reported that the LIFEPAK 35 entered pacing mode but the patient did not appear to capture during transcutaneous pacing."

Cause

What was observed during troubleshooting.

Example:
"Bench evaluation found intermittent therapy connection behavior that followed the pacing/therapy cable and resolved when a known-good compatible cable was installed."

Resolution

What action was taken.

Example:
"Removed the defective therapy cable from service, installed a verified replacement, confirmed pacing output and rate with a defibrillator analyzer, and completed operational testing successfully."

Helpful Details to Include (If Known)

Final Thought

A reported pacing failure requires careful separation of patient non-capture from actual device output failure. Protect the patient first, verify external accessories and connections, objectively test pacing performance with appropriate equipment, and escalate unresolved therapy faults without unnecessary internal disassembly. Clear CCR documentation preserves both the clinical complaint and the technical evidence.

That is successful troubleshooting.

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