MAUDE Adverse Event Report: CONMED CORPORATION PADPRO; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 2001H-C

Device Problem Sparking (2595)

Patient Problem Erythema (1840)

Event Date 11/22/2021

Event Type  malfunction  

Event Description

The patient presented to the iru (interventional radiology unit) for planned cardioversion.The defibrillator pads were placed in the anterior/posterior position ¿ the preferred positioning for cardioversion.The patient¿s chest was prepped correctly, he did not have excessive chest hair, and the pads were appropriately adhered to the chest and back.Conscious sedation was performed for the procedure.Biphasic synchronized cardioversion was performed at 200, 300, and 360 joules.During the third defibrillation, the nurse noticed a small spark on the upper left corner of the anterior defibrillation pad.The defibrillator pads were removed, the skin was noted to be red in both areas, but no burns were noted.

• Brand Name: PADPRO
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 13666528
• MDR Text Key: 286569042
• Report Number: 13666528
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2001H-C
• Device Catalogue Number: 2001H-C
• 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: 12/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male