BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250168 · Received November 6, 2014

    Report

    Report Number
    3008642652-2014-03721
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    November 6, 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 EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO COMMUNICATE WITH A MONITOR) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING FUNCTIONAL TESTING. UPON EVAL, ESD700 WAS INTERNALLY SHORTED ON THE DISTRIBUTION NODE PCA. THE CAUSE FOR THE TEST FAILURE WAS THE SHORTED ESD700 COMPONENT. THE ROOT CAUSE FOR THE INTERNALLY SHORTED ESD700 COMPONENT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS UNABLE TO COMMUNICATE WITH A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714851 LIFEVEST WCD 4000 SYSTEM MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA