BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2233021 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00221
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 18, 2011
    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 EVAL SUMMARY: DEVICE EVAL OF BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE CABLE RUNNING FROM THE DISTRIBUTION NODE TO ECG C AND ECG D HAD BROKEN WIRES INSIDE OF THE INSULATION. THE ROOT CAUSE OF THE CUT WIRES CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. ONCE THE CABLE WAS REPLACED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF AN UNRELATED COMPLAINT FOR ELECTRODE BELT SN (B)(4), A REPORTABLE EVENT WAS DISCOVERED. A CABLE ON THE ELECTRODE BELT WAS DEFECTIVE. THE PT 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 72 YR