BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2160482 · Received July 1, 2011

    Report

    Report Number
    3008642652-2011-00126
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 21, 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 (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE REVIEW OF A (B)(6) FEMALE PATIENT REVEALED SEVERAL CAN COMM FAULTS, BELT COMMUNICATION ERRORS, AND ABNORMAL SHUTDOWNS. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT TO DISCUSS THE DOWNLOAD. AS A RESULT OF THE CALL, THE PATIENT WAS ISSUED 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 62 YR