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

Model Number 2001Z-C

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Patient was burnt using a conmed padpro 2001z-c during cardioversion in the ep lab.Manufacturer response for defib pad, pad pro (per site reporter).Full investigation under way.

• 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: 11553283
• MDR Text Key: 241793090
• Report Number: 11553283
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2001Z-C
• Device Catalogue Number: 2001Z-C
• Device Lot Number: Y09152006
• 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: 03/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other