BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4650036 · Received March 30, 2015

    Report

    Report Number
    3008642652-2015-01636
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 25, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    NVK
    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) IS COMPLETE. THE REPORTED PROBLEM (UNABLE TO PERFORM DETECT AND TREAT) WAS CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE) WAS PULLED FROM THE STRAIN RELIEF. THE CAUSE OF THE TEST FAILURE WAS THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE OF THE PULLED DN TO REAR TE CABLE CANNOT BE POSITIVELY IDENTIFIED. 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 PERFORM THE DETECT AND TREAT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208871 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR NVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA