BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1082859 · Received July 25, 2008

    Report

    Report Number
    3002158293-2008-00328
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE- MONITOR - 04/2008. BATTERY PACK - 03/2008. SECOND BATTERY PACK- 09/2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR AND TWO BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR WAS FOUND TO HAVE A DEFECTIVE BATTERY CONNECTOR. THE CONNECTOR PINS WERE BENT. THE CONNECTOR WAS REPAIRED. THE MONITOR WAS RETESTED AND THEN RESTOCKED. THE ROOT CAUSE OF THE BENT PINS IS UNKNOWN, BUT IS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. THE BATTERY PACKS WERE FULLY FUNCTIONAL AND HAD NO DAMAGE TO THEIR CONNECTORS. THEY WERE RETESTED AND RESTOCKED. THE DAMAGED CONNECTOR ON THE MONITOR WAS REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE SYSTEM DOES NOT APPEAR TO BE WORKING. SUPPORT HAD HER CHECK THE PINS INSIDE THE MONITOR'S BATTERY WELL. SUPPORT HAD HER PLACE THE BATTERY PACKS ON THE BATTERY CHARGER AND THIS SHOWED THAT THE BATTERY PACKS WERE FULLY CHARGED. SUPPORT HAD HER ATTEMPT TO PUT A BATTERY PACK INTO THE MONITOR AND SHE STATED THAT IT WAS NOT FLUSH WITH THE BOTTOM OF THE MONITOR. SUPPORT SENT A LIFECOR TERRITORY MANAGER (TM) TO THE PATIENT TO REPLACE THE MONITOR AND BOTH BATTERY PACKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR