BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2820912 · Received October 9, 2012

    Report

    Report Number
    3008642652-2012-02686
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    July 10, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVAL OF BATTERY PACK SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY FAULTS) IS BEING INVESTIGATED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE IN THE CHARGER OR POWER ON A MONITOR. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY AT THE SUPPLIER, (B)(4). A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A PT'S BATTERY PACK WAS FAULTY. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA