BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4252856 · Received September 4, 2014

    Report

    Report Number
    3008642652-2014-02721
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 4, 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 BATTERY MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL RESPONSE BUTTONS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE REAR RESPONSE BUTTON WAS DEFECTIVE. THE CAUSE FOR THE FAILURE WAS ISOLATED TO WORN CONTACTS ON THE REAR RESPONSE BUTTON CABLE. THE WORN CABLE PRODUCED AN INTERMITTENT CONNECTION. THE ROOT CAUSE FOR THE WORN CONTACTS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED MONITOR SN (B)(4) TO REPORT THAT THE RESPONSE BUTTONS ARE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539749 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA