BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4862648 · Received June 18, 2015

    Report

    Report Number
    3008642652-2015-03938
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 17, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO POWER MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY WAS UNABLE TO POWER ON THE MONITOR OR RECHARGE. THE CAUSE FOR THE BATTERY FAILURE WAS ISOLATED TO AN OPEN F1 BATTERY FUSE. THE CAUSE FOR THE OPEN FUSE WAS EXCESSIVE CURRENT. THE ROOT CAUSE FOR THE EXCESSIVE CURRENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED BATTERY PACK SN (B)(4) AND REPORTED THAT THE BATTERY PACK WAS UNABLE TO POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398569 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA