BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941312 · Received April 11, 2014

    Report

    Report Number
    3008642652-2014-01065
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ZOLL LIFECORE CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 (WILL NOT POWER ON) WAS 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 CAUSE OF THE DEFECTIVE POWER SUPPLY UNIT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220173 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECORE CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR