MAUDE Adverse Event Report: STRYKER/PHYSIO-CONTROL, INC. LIFEPAK QUIK-COMBO; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Lot Number	526228
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During cardioversion patient sustained a minor burn believed to be attributed to the lifepac (quik-combo) equipment.

• Brand Name: LIFEPAK QUIK-COMBO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER/PHYSIO-CONTROL, INC.
• MDR Report Key: 25209332
• Report Number: MW5188380
• Device Sequence Number: 9810341
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: (01)00883873784945
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Lot Number: 526228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown