BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4080960 · Received July 9, 2014

    Report

    Report Number
    3008642652-2014-02122
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PROBLEMS (DAMAGED CABLE OR WIRES EXPOSED, CHECK THERAPY PAD MESSAGES) WAS CONFIRMED. AS RECEIVED THE ELECTRODE BELT FAILED INCOMING FUNCTIONAL TESTING. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN AND THE TEST FAILURE. THE ROOT CAUSE OF THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S WIFE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S ELECTRODE BELT HAD AN EXPOSED WIRE AND WAS GENERATING CHECK THERAPY PAD MESSAGES. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400960 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR