MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; 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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.Stryker determined that a faulty system pcb was the cause of the reported issue.The device was unrepairable and returned to the customer unrepaired.
Event or Problem Description
The customer contacted stryker to report that their device does not complete the boot-up process.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Event or Problem Description
The customer contacted stryker to report that their device does not complete the boot-up process.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Corrected data: section d10, returned to manufacturer on of the initial medwatch report indicates 05/07/2024; section d10, returned to manufacturer on of the initial medwatch report should indicate 04/24/2024.Additional manufacturer narrative: the system pcb was removed from the device and returned to stryker product analysis center (pac) for further analysis.The pac technician found the single board computer (sbc) card is corrupted and no longer accepting software changes.The root cause of the reported issue was the inoperative sbc card.The customer received a replacement device under the loaner trade program and agreed to have their device scrapped by stryker.The customer's device was therefore returned to stryker for scrap.

• 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: 19369582
• Report Number: 0003015876-2024-01707
• Device Sequence Number: 7619578
• Product Code: MKJ
• UDI-Device Identifier: 00883873988022
• UDI-Public: 00883873988022
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/25/2024

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: 99577-000046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2011
• 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