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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that their device was not completing the boot-up cycle.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.All the battery pins were replaced, as a precautionary measure, and the software has been updated to the latest available version.After completing this repair, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.The customer was advised to change the ac adapter.The cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that their device was not completing the boot-up cycle.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker product analysis center (pac) further investigated the reported event.The acpa was not returned to stryker, however an engineering analysis found a potential manufacturing discrepancy where the process adhesive could potentially bridge two solder pads within a voltage divider on the ac input pcb which could trigger the overvoltage protection of the acpa and make it enter a reset loop.This causes the acpa to not be able to power the device or charge the batteries.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17842638
• Report Number: 0003015876-2023-01791
• Device Sequence Number: 15249654
• Product Code: MKJ
• UDI-Device Identifier: 00883873871607
• UDI-Public: 00883873871607
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/09/2023

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: 99577-001966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2015
• 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