BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1001308 · Received February 19, 2008

    Report

    Report Number
    3002158293-2008-00060
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE: MONITOR - 02/2008. BATTERY PACK - 10/2007. BATTERY PACK - 12/2007. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF MONITOR, 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 A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. BOTH BATTERY PACKS HAD DAMAGED CONNECTORS. THE CONNECTORS WERE REPAIRED. THEN THE BATTERY PACKS WERE RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE BATTERY PACK CONNECTOR DAMAGE WAS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. THE DAMAGED CONNECTORS ON THE MONITOR AND BATTERY PACKS WERE REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR AND BATTERY PACKS. THE PT RECEIVED A REPLACEMENT MONITOR AND TWO REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    A LIFECOR PT SVC REP (PSR) CONTACTED LIFECOR CUSTOMER SUPPORT WHILE FITTING A FEMALE PT. THE PSR STATED, THAT SHE HAD REMOVED THE BATTERY PACK FROM THE SYS AND WHEN SHE PLACED IT BACK IN THE SYS, IT WOULD NOT ENGAGE. THE MONITOR WOULD NOT TURN ON. THE PT WAS PROVIDED WITH A REPLACEMENT 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 23 YR