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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and observed that the therapy transfer relay plug p24 cable to be pinched in front case.After replacing display shield, 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 a non-critical issue with their device.During evaluation stryker observed observed that the therapy transfer relay plug p24 cable to be pinched in front case.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 h11 additional mfg narrative of initial mdr indicates: a stryker service representative performed an initial evaluation of the customer¿s device and observed that the therapy transfer relay plug p24 cable to be pinched in front case.After replacing display shield, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Section h11 additional mfg narrative of initial mdr should indicate: a stryker service representative performed an initial evaluation of the customer¿s device and observed that the therapy transfer relay plug p24 cable to be pinched in front case.After replacing the therapy cable and display shield, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Stryker further evaluated the replaced therapy cable at the product analyses center (pac) and the cause of the reported issue was determined to be due to the damaged red wire by a case screw.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the therapy transfer relay plug p24 cable to be pinched in front case.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: 22918978
• Report Number: 0003015876-2025-01757
• Device Sequence Number: 13203606
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/26/2025

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: 08/05/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2012
• 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