BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2140310 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00055
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 14, 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 MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST/CHECK BELT MESSAGES) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WAS FOUND TO HAVE DEFECTIVE COMPONENTS U44, U54 AND U66. (B)(4). THE ROOT CAUSE OF THE DEFECTIVE COMPONENTS CANNOT BE POSITIVELY IDENTIFIED. AS A RESULT OF THE DEFECTIVE COMPONENTS, THE MONITOR WAS UNABLE TO PERFORM A BASELINE. NO ADVERSE EVENT RESULTED FROM DEFECTIVE COMPONENTS. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER DEVICE IS CONSTANTLY ALARMING TO "ADJUST/CHECK BELT." THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR