MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 KIT, REPLACEMENT BATTERY, LPCR2, MULTI; AUTOMATED EXTERNAL DEFIBRILLATOR BATTERY

Catalog Number	11141-000165
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their battery caught fire.This may lead to injury as a result of the fire.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Additional Manufacturer Narrative
Section d4, lot/serial no., has been changed.
Event or Problem Description
The customer contacted stryker to report that their battery caught fire.This may lead to injury as a result of the fire.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The faulty battery was not returned to stryker for evaluation as an investigation would be unable provide any additional information.The product images were provided, which confirmed the reported issue.However, the root cause of the reported issue could not be determined.The battery was archived by the customer.
Event or Problem Description
The customer contacted stryker to report that their battery caught fire.This may lead to injury as a result of the fire.There was no patient use associated with the reported event.

• Brand Name: KIT, REPLACEMENT BATTERY, LPCR2, MULTI
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR BATTERY
• 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: 23875210
• Report Number: 0003015876-2025-02721
• Device Sequence Number: 12155381
• Product Code: MKJ
• UDI-Device Identifier: 00883873867792
• UDI-Public: 00883873867792
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P170018
• 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,Followup
• Report Date (Section B): 05/11/2026

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: Lay User/Patient
• Device Catalogue Number: 11141-000165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/22/2026; 04/29/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/22/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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