BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4232305 · Received September 17, 2014

    Report

    Report Number
    3008642652-2014-02897
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 16, 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 BATTERY PACK SN (B)(4) IS STILL UNDERWAY. THE REPORTED PROBLEM (DOES NOT POWER ON MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WAS NON-FUNCTIONAL IN A MONITOR AND CHARGER. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A BATTERY PACK SN (B)(4) INDICATING THAT THE BATTERY WAS UNABLE TO POWER ON A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573865 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA