BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3842559 · Received February 21, 2014

    Report

    Report Number
    3008642652-2014-00503
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 12, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER/MODEM WOULD NOT POWER ON. UPON EVALUATION, THE POWER SUPPLY UNIT WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO POWER ON IS THE DEFECTIVE POWER SUPPLY UNIT. THE ROOT CAUSES OF THE DEFECTIVE POWER SUPPLY UNIT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER WOULD NOT POWER ON. THE PT WAS ISSUED A REPLACEMENT CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109862 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR