BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6149348 · Received December 6, 2016

    Report

    Report Number
    3008642652-2016-08946
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ZOLL MANUFACTURING 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 EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO CHARGE A BATTERY) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER/MODEM WAS UNABLE TO RECHARGE A BATTERY. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED Q1 CURRENT-CONTROLLING TRANSISTOR ON THE BEDSIDE PCA. THE ROOT CAUSE FOR THE SHORTED Q1 TRANSISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) AND REPORTED THAT THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE A BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797783 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1