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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device unexpectedly powered off.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and observed that the device's batteries were at an 11% charge level and manufactured in 2020, which makes them past the recommended use life.The customer was instructed to replace the old batteries in the device.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device unexpectedly powered off.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker further evaluated the device's electronic records from the event and was able to verify the reported issue.

• 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: 21257429
• Report Number: 0003015876-2025-00200
• Device Sequence Number: 9053888
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/16/2025

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: 99577-001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2014
• 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