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

Model Number 11996

Device Problems Melted (1385); Noise, Audible (3273)

Patient Problem Skin Tears (2516)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Patient was a cardioversion with anesthesia, when shock delivered heard a small pop and then smelled burning skin.Quick patch removed and noted that black wire had melted and took a small area of skin off of the patient.Manufacturer response for electrode pacing defibrillation quick combo adult, (brand not provided) (per site reporter.) we are waiting for a response.

• Brand Name: EDGE SYSTEM
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 13558527
• MDR Text Key: 285817817
• Report Number: 13558527
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2022

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
• Device Operator: Other
• Device Model Number: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 129340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male