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	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
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 power pcb, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Event or Problem Description
The customer contacted stryker to report that their device does not completing boot-up cycle during initial power on.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Section d9 returned to manufacturer on of initial mdr indicates: 12/27/2023 section d9 returned to manufacturer on of initial mdr should indicate: 12/18/2024 stryker further evaluated the replaced part at the product assessment center (pac) and was not able to duplicate reported issue.The cause of the reported issue was isolated to the power pcb assembly, however further root cause could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device does not completing boot-up cycle during initial power on.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.

• 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: 18466467
• Report Number: 0003015876-2024-00037
• Device Sequence Number: 17921410
• Product Code: MKJ
• UDI-Device Identifier: 00883873877081
• UDI-Public: 00883873877081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 99577-001588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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