BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2912905 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03098
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PROBLEM (FRAYED WIRES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE REAR THERAPY ELECTRODES WAS RIPPED FROM THE DN, EXPOSING WIRES. ADDITIONALLY, THE REAR THERAPY ELECTRODE INTERCONNECT CABLE WAS CORRODED. THE ROOT CAUSE FOR THE DAMAGED CABLE WAS EXCESSIVE FORCE. THE ROOT CAUSE FOR THE CORRODED CABLE WAS INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT WIRES WERE FRAYED ON THE PATIENT¿S ELECTRODE BELT. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR