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

Model Number 11996

Device Problems Smoking (1585); Sparking (2595)

Patient Problems Non specific EKG/ECG Changes (1817); Asystole (4442)

Event Date 04/30/2023

Event Type  malfunction  

Event Description

Patient went into asystole initiating a cpr call and a crash cart to be brought into the room.The patient was then connected to a cardiac monitor and defibrillation pads were applied.The patient¿s heart rhythm changed requiring defibrillation.The defibrillator was charged, and a shock was delivered.Upon delivery of the shock, staff noticed a puff of smoke that was emitted from the pads.These pads were replaced, and a second shock was delivered, whereupon staff noticed a spark emitted from the pads.At this point the pads and the defibrillator were both replaced, and two more rounds of shock were applied without incident.Both sets of pads and the defibrillator were sequestered and returned to the vendor for evaluation.Manufacturer response for automated external defibrillators (non-wearable), edge system (per site reporter).Defibrillator was returned to the manufacturer by biomedical engineering for failure analysis.Defibrillator pads were returned to materials management to be returned to the manufacturer for failure analysis.Manufacturer response for defibrillator, lifepak 20e (per site reporter).Case was opened with the manufacturer for the evaluation of the defibrillator.The defibrillator was packaged and sent to the manufacturer for failure analysis.Manufacturer response for automated external defibrillators (non-wearable), edge system (per site reporter).Biomedical engineering contacted the manufacturer to conduct a failure analysis on the defibrillator.Materials management will return the defective pads to the manufacturer for failure analysis.

Event Description

Patient went into asystole initiating a cpr call and a crash cart to be brought into the room.The patient was then connected to a cardiac monitor and defibrillation pads were applied.The patient¿s heart rhythm changed requiring defibrillation.The defibrillator was charged, and a shock was delivered.Upon delivery of the shock, staff noticed a puff of smoke that was emitted from the pads.These pads were replaced, and a second shock was delivered, whereupon staff noticed a spark emitted from the pads.At this point the pads and the defibrillator were both replaced, and two more rounds of shock were applied without incident.Both sets of pads and the defibrillator were sequestered and returned to the vendor for evaluation.Manufacturer response for automated external defibrillators (non-wearable), edge system (per site reporter).Defibrillator was returned to the manufacturer by biomedical engineering for failure analysis.Defibrillator pads were returned to materials management to be returned to the manufacturer for failure analysis.Manufacturer response for defibrillator, lifepak 20e (per site reporter).Case was opened with the manufacturer for the evaluation of the defibrillator.The defibrillator was packaged and sent to the manufacturer for failure analysis.Manufacturer response for automated external defibrillators (non-wearable), edge system (per site reporter).Biomedical engineering contacted the manufacturer to conduct a failure analysis on the defibrillator.Materials management will return the defective pads to the manufacturer for failure analysis.

• Brand Name: EDGE SYSTEM
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 16983234
• MDR Text Key: 315760088
• Report Number: 16983234
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

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: 11996-000017
• Device Lot Number: 227023
• 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: 05/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male