BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844822 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02921
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 1, 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLES HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND REAR THERAPY ELECTRODES WAS RIPPED FROM THE DN. THE ROOT CAUSE OF THE DAMAGED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6), MALE, PATIENT, CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CABLES ON HIS ELECTRODE BELT WERE DAMAGED. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 63 YR