BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2161226 · Received November 2, 2010

    Report

    Report Number
    3002158293-2010-01131
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    June 28, 2010
    Report Date
    October 27, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (GEL RELEASE FLAGS) HAS BEEN CONFIRMED. THE CAUSE OF THE GEL RELEASE FLAG WAS DUE TO A DAMAGED CABLE. THE BLACK GEL FIRE WIRE WAS DISCONNECTED FROM THE DISTRIBUTION NODE. THE MONITOR RECOGNIZED THE OPEN GEL FIRE CIRCUIT, SHOWING THAT THE GEL FIRE CIRCUIT HAD BEEN BLOWN. THE ROOT CAUSE OF THE DISCONNECTED WIRES CANNOT BE POSITIVELY DETERMINED, BUT WAS LIKELY CAUSED BY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE RECEIVED A MESSAGE SAYING HIS BELT WAS DEFECTIVE AND NEEDED A NEW ONE. A REVIEW OF THE PT'S DOWNLOAD REVEALED A "GEL PREVIOUSLY RELEASED" FLAG. THE PT DID NOT HAVE ANY LEAKING GEL ON HIS ELECTRODE BELT. 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 60 YR