BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4093048 · Received September 10, 2014

    Report

    Report Number
    3008642652-2014-02774
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT RUN DETECT AND TREAT TEST) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THE CABLE WAS CUT BETWEEN THE FRONT THERAPY ELECTRODE AND ECG "A". THE CAUSE OF THE TEST FAILURE IS THE DAMAGED CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS UNABLE TO RUN THE DETECT AND TREAT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559622 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA