BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2050106 · Received April 5, 2011

    Report

    Report Number
    3002158293-2011-00381
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 1, 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 (INTERMITTENT TRUNK CABLE) HAS BEEN CONFIRMED. UPON EVALUATION, THE TRUNK CABLE WAS FOUND TO BE INTERMITTENT. THE ROOT CAUSE FOR THE INTERMITTENT CONNECTION CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF PHYSICAL DAMAGE TO AN INTERNAL WIRE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    DURING SERVICING OF ELECTRODE BELT (B)(4) FOR AN UNRELATED COMPLAINT, A REPORTABLE PROBLEM WAS DISCOVERED. THE TRUNK CABLE HAD AN INTERMITTENT CONNECTION. THE PT RECEIVED A REPLACEMENT 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 65 YR