BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3191052 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01639
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE ELECTRODE BELT FAILED THE INSULATION RESISTANCE AND FUNCTIONAL FALL-OFF TESTS. UPON EVALUATION, THERE WAS A SHORT AT THE PULSE WIRE INSIDE THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND THE REAR THERAPY ELECTRODE (TE). THE CAUSE FOR THE TEST FAILURES AND ALARMS IS THE SHORTED PULSE WIRE. THE ROOT CAUSE OF THE SHORTED PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED PULSE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT THAT SHE WAS RECEIVING FREQUENT "ADJUST OR CHECK BELT" MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283188 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR