BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8744710 · Received June 28, 2019

    Report

    Report Number
    3008642652-2019-04531
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 26, 2019
    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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO POWER ON MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO RECHARGE OR POWER ON A MONITOR. THE F1 FUSE WAS OPEN. THE CAUSE FOR THE OPEN FUSE WAS EXCESSIVE CURRENT. THE ROOT CAUSE FOR THE EXCESSIVE CURRENT WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A BATTERY PACK AND REPORTED THAT THE BATTERY WAS UNABLE TO POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536601 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005036

    Patients

    Seq Age Sex Outcome Treatment
    1