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

Model Number	15
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue of the event code.The event code was cleared from the memory of the device and thereafter did not return.The unexpected shut down could not be duplicated with charged batteries.It was noted that the device had issued a "replace battery" warning in the software log.The customer indicated the batteries were replaced at the time of the event to resolve the unexpected shutdown.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted stryker to report that their device unexpectedly shut down and had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The cause of the unexpected shut down was determined to be due to the depleted battery.
Event or Problem Description
The customer contacted stryker to report that their device unexpectedly shut down and had logged an event code in the memory which is related to a potential issue of the device to deliver energy.There was no patient involvement reported with the event.

• 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: 18357201
• Report Number: 0003015876-2023-02421
• Device Sequence Number: 12368903
• Product Code: MKJ
• UDI-Device Identifier: 00883873877081
• UDI-Public: 00883873877081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2024

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: 11/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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