BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3191004 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01648
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEL WAS NOT POWERING UP. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE POWER SUPPLY BRICK THAT WAS NOT OUTPUTTING ANY DC VOLTAGE. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY BRICK COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE BROTHER IN-LAW OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER/MODEM WASN'T WORKING. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283436 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR