BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1872475 · Received October 8, 2010

    Report

    Report Number
    3002158293-2010-01034
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED WIRES/ARRHYTHMIA ALARMS) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS DISCOVERED THAT THE TRUNK CABLE CONNECTOR WAS BROKEN. THE ROOT CAUSE OF THE BROKEN TRUNK CABLE CONNECTOR WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE (B)(6) OLD FEMALE PATIENT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE IS GETTING A MESSAGE STATING HER SYSTEM IS DISABLED AND SHE NEEDS TO CALL AN AMBULANCE. A REVIEW OF THE PATIENT'S DOWNLOAD REVEALED SEVERAL ASYSTOLE EVENTS. THE PATIENT'S ELECTRODE BELT WAS REPLACED.

    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 42 YR