BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4031091 · Received July 17, 2014

    Report

    Report Number
    3008642652-2014-02262
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 BELT SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (CANNOT BASELINE) IS BEING INVESTIGATED. AS RECEIVED, THE BELT FAILED INCOMING FUNCTIONAL TESTING. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT. THE PATIENT RECEIVED A REPLACEMENT BELT.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING A (B)(6) MALE PATIENT AND REPORTED THAT THE PATIENT COULD NOT BE BASELINED. THE PATIENT WAS ISSUED A REPLACEMENT BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420682 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR