MAUDE Adverse Event Report: CONMED CORPORATION PADPRO; MULTIFUNCTION CARDIAC ELECTRODE, ADULT

Catalog Number 2001M-C

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 06/01/2018

Event Type  malfunction  

Event Description

Conmed padpro defibrillation/ cardioversion electrode spark during cardioversion.

• Brand Name: PADPRO
• Type of Device: MULTIFUNCTION CARDIAC ELECTRODE, ADULT
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 7817555
• MDR Text Key: 118269362
• Report Number: 7817555
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y03271809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Date Report to Manufacturer: 08/27/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA