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

Model Number	REF: 2001H-C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2017
Event or Problem Description
A spark/ flash from a defib pad occurred during a cardioversion.

• Brand Name: PAD PRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS
• Manufacturer (Section D): CONMED CORP.; utica NY 13502
• MDR Report Key: 7059113
• Report Number: MW5073565
• Device Sequence Number: 821104
• Product Code: MKJ
• UDI-Device Identifier: 10653405064299
• UDI-Public: (01)10653405064299
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 147