BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2190038 · Received June 29, 2011

    Report

    Report Number
    3008642652-2011-00118
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 29, 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 (DAMAGED CONNECTOR) 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 PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A TERRITORY MANAGER (TM) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PT TO REPORT THAT THE PT'S ELECTRODE BELT COULD NOT CONNECT TO THE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR