BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1172618 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00460
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    May 14, 2008
    Report Date
    September 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. IT WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DAMAGED CLIP CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO FORCIBLE REMOVAL OF THE BATTERY PACK FROM THE MONITOR WITHOUT PRESSING THE LOCKING TAB BEFORE PULLING. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A RECENT DOWNLOAD FROM A FEMALE PT REVEALED SEVERAL "BATTERY PACK FAULT" FLAGS. FURTHER REVIEW OF THE FLAGS SHOWED THAT THESE ALL OCCURRED ON THE SAME BATTERY PACK. LIFECOR CUSTOMER SUPPORT CALLED THE PT AND EXCHANGED THE BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR