BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3941333 · Received April 11, 2014

    Report

    Report Number
    3008642652-2014-01061
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 16, 2014
    Report Date
    April 3, 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 CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGE FAULTS) WAS CONFIRMED. UPON EVALUATION, THE Q1 TRANSISTOR WAS SHORTED ON THE BEDSIDE BOARD. THE CAUSE OF THE CHARGER FAULTS IS THE SHORTED COMPONENT. THE ROOT CAUSE OF THE SHORTED COMPONENTS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED TRANSISTOR. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S SON CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CHARGER FAULTS. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220151 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR