BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEBEST WCD 4000 SYSTEM

    MDR report key: 4252873 · Received September 4, 2014

    Report

    Report Number
    3008642652-2014-02718
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 3, 2014
    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 SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO CHARGE A BATTERY PACK) WAS CONFIRMED. AS RECEIVED, THE CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. UPON EVALUATION, THE U13 8-BIT CMOS FLASH MICRO-CONTROLLER WAS INTERNALLY SHORTED. THE CAUSE OF THE INABILITY TO CHARGE A BATTERY PACK IS THE INTERNALLY SHORTED U13 COMPONENT. THE ROOT CAUSE OF THE INTERNALLY SHORTED COMPONENT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE INTERNALLY SHORTED COMPONENT.

    Description of Event or Problem · 1

    ZOLL DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM SN (B)(4) TO REPORT THAT THE CHARGER/MODEM WAS UNABLE TO CHARGE A BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539732 LIFEBEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA