FDA Adverse Event Malfunction Summary report: N

LIFEVEST WCD 3000 SYSTEM

MDR report key: 1062818 · Received June 18, 2008

Report

Report Number: 3002158293-2008-00277
Event Type: Malfunction
Date Received: June 18, 2008
Date of Event: April 15, 2008
Report Date: June 18, 2008
Manufacturer: ZOLL LIFECOR CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN 79004066 HAS BEEN COMPLETED. THE PROBLEM WAS CONFIRMED. UPON FURTHER INSPECTION, THE ELECTRODE BELT HAD PINS THAT WERE BENT INSIDE THE CONNECTOR. THE ROOT CAUSE OF THE BENT PINS WAS PROBABLY EXCESSIVE FORCE APPLIED TO THE CONNECTOR DURING MATING. THE CONNECTOR WAS FORCED INTO THE MONITOR WHICH DEFEATED THE CONNECTOR KEYING MECHANISM AND ALLOWED THE PINS TO MISALIGN WITH THE MATING SOCKETS. THE DAMAGED ELECTRODE BELT CONNECTOR WAS REPLACED. THE ELECTRODE BELT WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

Description of Event or Problem · 1

A LIFECOR PATIENT SERVICES REPRESENTATIVE (PSR) CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT HAD BENT PINS INSIDE THE ELECTRODE BELT CONNECTOR. THE PSR HAD GONE TO DO A FOLLOW-UP ON THE PATIENT BEFORE HE WAS DISCHARGED. THE PATIENT WAS UNDER THE IMPRESSION THAT HE HAD TO DISCONNECT THE ELECTRODE BELT EVERY TIME HE WENT TO THE BATHROOM. THE PSR REPLACED THE PATIENT'S ELECTRODE BELT AND REMIND THE PATIENT TO NEVER DISCONNECT THE ELECTRODE BELT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIFEVEST WCD 3000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL LIFECOR CORPORATION	WCD 3100	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR