BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2018197 · Received March 9, 2011

    Report

    Report Number
    3002158293-2011-00247
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 2, 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 (CHECK TE MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THE PULSE WIRE INSIDE THE DISTRIBUTION NODE WAS BROKEN. THE ROOT CAUSE FOR THE BROKEN WIRE CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY DUE TO A FAULTY SOLDER CONNECTION. ONCE THE PULSE WIRE WAS REFLOWED, THE BELT WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE BROKEN WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT WAS GETTING EXCESSIVE CHECK THERAPY PAD AND ADJUST BELT MESSAGES, DESPITE THE GARMENT BEING ASSEMBLED PROPERLY THE TE'S MAKING CONTACT WITH THE PT'S BODY. THE PT WAS ISSUED 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 68 YR