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

Model Number	15
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During routine testing by stryker the customer's device failed to deliver energy.In this state, the device may not be able to provide defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.After replacing the therapy pcb assemblies, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Additional Manufacturer Narrative
Stryker further evaluated the therapy pcb, and isolated the cause as a failed therapy pcb.
Event or Problem Description
During routine testing by stryker the customer's device failed to deliver energy.In this state, the device may not be able to provide defibrillation therapy if needed.There was no patient involvement reported with the event.
Event or Problem Description
During routine testing by stryker the customer's device failed to deliver energy.In this state, the device may not be able to provide defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Stryker further evaluated the removed therapy pcb assembly and determined that the root cause is resistors r1 and r6 are electrically out of tolerance.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 14192474
• Report Number: 0003015876-2022-00614
• Device Sequence Number: 11856864
• Product Code: MKJ
• UDI-Device Identifier: 00883873911457
• UDI-Public: 00883873911457
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2023

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: 99577-001268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 04/12/2023
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/15/2022; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2011
• 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