BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2190042 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00115
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 21, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    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 (BELT UNABLE TO CONNECT WITH THE MONITOR) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS FOUND THAT THE TRUNK CABLE CONNECTOR WAS BROKEN. THE ROOT CAUSE OF THE BROKEN CONNECTOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. THE BELT WAS FULLY FUNCTIONAL ONCE THE TRUNK WAS REPLACED. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE SYSTEM GAVE HIM A MESSAGE THAT THE DEVICE HAS A PROBLEM AND CANNOT BE USED. THE PT LATER REPORTED THAT THERE WAS A CRACK IN THE BELT CONNECTOR. THE PT 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 CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR