MAUDE Adverse Event Report: CONMED CORP. PAD PRO; AUTOMATED EXTERNAL DEFIBRILLATORS

Model Number REF: 2001H-C

Device Problems Sparking (2595); Flare or Flash (2942)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2017

Event Type  No Answer Provided  

Event Description

A spark/ flash from a defib pad occurred during a cardioversion.

• Brand Name: PAD PRO
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS
• Manufacturer (Section D): CONMED CORP.; utica NY 13502
• MDR Report Key: 7059113
• MDR Text Key: 93109624
• Report Number: MW5073565
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 10653405064299
• UDI-Public: (01)10653405064299
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REF: 2001H-C
• Device Catalogue Number: P/N 15837 REV C 03/16
• Device Lot Number: Y05081702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 147