FDA Adverse Event Malfunction Summary report: N

CONMED PADPRO ADAPTERS

MDR report key: 632121 · Received August 23, 2005

Report

Report Number: 632121
Event Type: Malfunction
Date Received: August 23, 2005
Date of Event: August 22, 2005
Report Date: August 23, 2005
Manufacturer: CONMED CORP.
Product Code: MKJ
Product Problem: Yes
Report Source: User Facility report
Reporter Location: MO, US

Narratives

Description of Event or Problem · 1

THE CONMED PADPRO ADAPTER IS USED FOR CONNECTING THE CONMED EXTERNAL DEFIBRILLATOR PADS TO ANOTHER MANUFACTURER'S DEFIBRILLATOR. THE ITEM HAS A PLASTIC HOUSING AND TETHER CABLE SO THE ADAPTER CAN BE ATTACHED TO THE DEFIBRILLATOR AND NOT MIS-PLACED. THE PROBLEM IS THAT THE PLASTIC BREAKS AND THE TETHER IS NO LONGER ATTACHED, CAUSING THE ADAPTER TO BE MISPLACED AND NOT AVAILABLE FOR USE. CONMED MAY BE AWARE OF THIS ISSUE. ORIGINAL INSTALLATION OF THIS ADAPTER BY CONMED WAS DONE WITH THE ADDITION OF TIE WRAP, IN ORDER TO REINFORCE THE CONNECTION OF THE TETHER TO THE HOUSING.

Description of Event or Problem · 1

1. PLEASE ADVISE THE NUMBER OF COMPLAINTS RECEIVED REGARDING THIS TYPE OF EVENT OCCURRING. IS THIS FAILURE OCCURRING AT A HIGHER THAT EXPECTED RATE OF OCCURANCE? RESPONSE: THE REPORTED COMPLAINT DATE WAS 08/2005. THE LOT CODE ON THE REPORTED DEVICE WAS 0312011. THIS INDICATES A MANUFACTURE DATE OF 12/2003. THIS IS THE ONLY COMPLAINT THAT CO HAS RECEIVED FOR ANY OF THE DEFIB PAD ADAPTERS MANUFACTURED AND SOLD BY CONMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONMED PADPRO ADAPTERS	ADAPTER CABLE	MKJ	CONMED CORP.	*	0312011

Patients

Seq	Age	Sex	Outcome	Treatment
1	*