BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7185989 · Received January 12, 2018

    Report

    Report Number
    3008642652-2018-00442
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 5, 2017
    Report Date
    January 10, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005036
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS, WON'T POWER ON MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO POWER ON A MONITOR OR CHARGE. THE CAUSE FOR THE FAILURE WAS ISOLATED OT A DEPLETED TRI-CELL (0.012V). THE ROOT CAUSE OF THE DEFECTIVE TRI-CELL WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT A PATIENT WAS RECEIVING BATTERY FAULTS AND ONE OF THE PATIENT'S BATTERIES WOULDN'T POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29645 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005036

    Patients

    Seq Age Sex Outcome Treatment
    1