BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2117807 · Received May 9, 2011

    Report

    Report Number
    3002158293-2011-00529
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 5, 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 OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION THE ELECTRODE BELT CABLE WAS FOUND TO HAVE INTERNAL WIRE DAMAGE WITHIN THE C AND D ASSEMBLY. THE CAUSE FOR THE INTERNAL DAMAGE CANNOT BE POSITIVELY DETERMINED. UPON FURTHER EVALUATION THE ELECTRODE BELT CONNECTOR WAS FOUND TO BE 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 DAMAGE CABLE AND CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE IS RECEIVING CONSTANT ALARMS FOR THE ELECTRODES NOT MAKING CONTACT WITH HIS BODY. 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 DEFIRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR