MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. EDGE SYSTEM; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	11996
Health Effect - Clinical Codes	Burn(s) (1757); Tachycardia (2095)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was undergoing vt [ventricular tachycardia] ablation, pt was defibrillated and the patient sustained a burn.The pads were changed and noted that similar pads had less gel/adhesive than others from different lots.Stryker was contacted.

• Brand Name: EDGE SYSTEM
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 22317858
• Report Number: 22317858
• Device Sequence Number: 8948069
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: (01)00883873784938
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/17/2025
• Report Date (Section F): 06/18/2025

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: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 501075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 06/18/2025