MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device failed to provide shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and observed that the device failed to provide shock.After replacing the therapy pcb assembly and completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Additional Manufacturer Narrative
Section h6: results code of initial mdr indicates: electrical problem identified.Section h6: results code of initial mdr should indicate: no device problem found.Section h6: conclusion code of initial mdr indicates: cause traced to component failure.Section h6: conclusion code of initial mdr should indicate: cause traced to user section h11: additional mfg narrative of initial mdr indicates: a stryker service representative performed an initial evaluation of the customer¿s device and observed that the device failed to provide shock.After replacing the therapy pcb assembly and completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Section h11 additional mfg narrative of initial mdr should indicate: a stryker field service representative performed an initial evaluation of the customer¿s device and observed that the device failed to provide shock.The root cause of the reported issue was traced to the technician use error during the pacing test.The therapy pcb was replaced as a precautionary measure.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device failed to provide shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 20077398
• Report Number: 0003015876-2024-02493
• Device Sequence Number: 20439020
• Product Code: MKJ
• UDI-Device Identifier: 00883873871683
• UDI-Public: 00883873871683
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown