BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2882153 · Received November 13, 2012

    Report

    Report Number
    3008642652-2012-02940
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 21, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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) WAS CONFIRMED. UPON RECEIPT THE BLACK PULSE WIRE WAS OPEN IN THE TRUNK CABLE INSULATION AND THE ELECTRODE BELT FAILED THE THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE ALARMS AND THE TEST FAILURE WAS THE OPEN BLACK PULSE WIRE IN THE TRUNK CABLE INSULATION. THE ROOT CAUSE FOR THE OPEN WIRE CANNOT BE POSITIVELY DETERMINED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REORT ADJUST BELT OR CHECK BELT MESSAGES. 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 61 YR