BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4321206 · Received December 2, 2014

    Report

    Report Number
    3008642652-2014-04635
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 7, 2014
    Report Date
    December 1, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETTING) WAS CONFIRMED. AS RECEIVED, THE CHARGER WAS RESETTING. UPON EVALUATION, THE Q1 CURRENT CONTROLLING TRANSISTOR WAS INTERNALLY SHORTED ON THE BEDSIDE BOARD, THE Y1 ((B)(4)) COMPONENT ON THE BEDSIDE BOARD WAS DEFECTIVE, AND THERE WAS LIQUID DAMAGE ON THE BATTERY BOARD. THE CAUSE OF THE RESETTING IS THE INTERNALLY SHORTED Q1 COMPONENT, THE DEFECTIVE Y1 COMPONENT, AND THE DAMAGED BATTERY BOARD. THE ROOT CAUSE OF THE INTERNALLY SHORTED Q1 COMPONENT CANNOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE OF THE DEFECTIVE Y1 COMPONENT CANNOT BE POSITIVELY IDENTIFIED. THE ROOT CAUSE OF THE LIQUID DAMAGED BATTERY BOARD IS LIKELY INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED CHARGER/MODEM SN (B)(4) INDICATING THAT IT RESETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777530 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA