BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1048067 · Received May 19, 2008

    Report

    Report Number
    3002158293-2008-00214
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE. MONITOR. BATTERY PACK-02/2008. BATTERY PACK-02/2008. DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR, BOTH 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 UNK, BUT IS LIKELY, DUE TO BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. BOTH 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 PT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    THE NURSE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT HAS NO IDEA HOW THE USE THE DEVICE. SUPPORT SENT A PT SERVICES REP ( PSR) TO RETAIN THE PT AND THE NURSE. THE PSR ARRIVED AND FOUND THAT NEITHER BATTERY PACK WOULD FIT INTO THE MONITOR. THE PSR REPLACED THE PT'S MONITOR AND 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 58 YR