BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1021904 · Received March 28, 2008

    Report

    Report Number
    3002158293-2008-00134
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 27, 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

    MONITOR - 2008. BATTERY PACK - 2008. BATTERY PACK 2008. DEVICE EVALUATIONS OF MONITOR BATTERY PACK, AND BATTERY PACK 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 A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. BATTERY PACK WAS FULLY FUNCTIONAL. IT WAS RESTOCKED. BATTERY PACK HAD A DAMAGED CONNECTOR AND MISMATCHED CELLS. THE ROOT CAUSE OF THE BENT PINS IS UNK, BUT IS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. THE ROOT CAUSE OF THE DEFECTIVE CELLS IS NOT KNOWN, BUT WAS PROBABLY DUE TO EXCESSIVE DISCHARGING. THE BATTERY PACK WAS REPAIRED, RETESTED AND RESTOCKED. THE DAMAGED CONNECTOR ON THE MONITOR. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT NEITHER BATTERY PACK WOULD POWER UP THE MONITOR. PT LOOKED INTO THE BATTERY WELL AND THERE DID NOT APPEAR TO BE ANY DAMAGE. SUPPORT SENT A LIFECOR PT SERVICES REP (PSR) TO THE PT TO EXCHANGE 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 58 YR