BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2160484 · Received July 1, 2011

    Report

    Report Number
    3008642652-2011-00121
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 30, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY PAD MESSAGES; ADJUST/CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT CABLE WAS DAMAGED AT THE DISTRIBUTION NODE (DN). THE DN TO REAR 2 WIRE THERAPY ELECTRODE PORTION OF THE CABLE WAS PULLED FROM THE STRAIN RELIEF AT THE DN. THE DAMAGE TO THE CABLE CAUSED BOTH REAR THERAPY ELECTRODES TO DEPLOY GEL. THE CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT RECEIVING CONSTANT CHECK THERAPY PAD MESSAGES AND ADJUST/CHECK BELT MESSAGES. 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 56 YR