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

Catalog Number	11140-000098
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
A customer contacted stryker to report that the power supply of their device experienced a short circuit and ignited.The fire was quickly extinguished.No injuries or property damage were reported.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
The ac power adapter (acpa) was returned to stryker for evaluation.Stryker product assessment center (pac) evaluated the returned part and confirmed through visual inspection that the acpa and accompanied ac power cord were severely burnt.Based on the reported information and the remains from the acpa and associated cable, it could not be conclusively determined whether the acpa itself or an external source contributed to the reported issue.A conclusive cause could not be determined.The acpa was archived by stryker.
Event or Problem Description
A customer contacted stryker to report that the power supply of their device experienced a short circuit and ignited.The fire was quickly extinguished.No injuries or property damage were reported.There were no reports 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: 23708752
• Report Number: 0003015876-2025-02531
• Device Sequence Number: 18804028
• Product Code: MKJ
• UDI-Device Identifier: 07613327666656
• UDI-Public: 07613327666656
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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 Catalogue Number: 11140-000098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK 15 AC TO DC POWER ADAPTER, SUB-BRAND 3000
• Patient Sex: Unknown