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

Model Number	15
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer's device and duplicated the reported issue.The device is not repairable.Stryker continues to investigate the reported failure 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 their device would not power up.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Event or Problem Description
The customer contacted stryker to report their device would not power up.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and was able to duplicate and verify the reported issue.The root cause of the reported issue was determined to be due to the system pcb assembly.It was confirmed that the device cannot be repaired.The device was returned to the customer unrepaired per their request.The device will be scrapped by customer.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 18735646
• Report Number: 0003015876-2024-00365
• Device Sequence Number: 12335281
• Product Code: MKJ
• UDI-Device Identifier: 00883873988039
• UDI-Public: 00883873988039
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/18/2024

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: 99577-000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2009
• 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