BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2231371 · Received July 26, 2011

    Report

    Report Number
    3008642652-2011-00283
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 12, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE/WIRES EXPOSED) HAS BEEN CONFIRMED. AS RECEIVED, THE TRUNK CABLE WAS RIPPED FROM THE STRAIN RELIEF AND WIRES WERE EXPOSED. THE ROOT CAUSE OF THE DAMAGED TRUNK CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRUNK CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT WHILE THE NURSING STAFF WAS HELPING THE PATIENT CHANGE, THE BELT CONNECTOR PULLED OUT OF THE MONITOR AND EXPOSED WIRES. THE PATIENT WAS PROVIDED WITH 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 65 YR