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

Model Number	15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that their device power button had to be pressed multiple times power on.Once the device did power on, it would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device power button had to be pressed multiple times power on.Once the device did power on, it would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker troubleshoot the issue with the customer and determined the ac power adapter (acpa) needed to be replaced.The customer's acpa was not returned for evaluation, however, stryker determined that the likely cause of the reported issue was due to process adhesive on one of the device¿s ac input pcbs.This can trigger the overvoltage protection of the ac power adapter and may result in the device being unable to power on or charge the batteries.The customer will be sent a replacement acpa.

• 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: 17764028
• Report Number: 0003015876-2023-01676
• Device Sequence Number: 20606433
• Product Code: MKJ
• UDI-Device Identifier: 00883873871751
• UDI-Public: 00883873871751
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 99577-001951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-10/13/2023-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown