BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSAIRE

    MDR report key: 1210763 · Received October 22, 2008

    Report

    Report Number
    2128677-2008-00002
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    VIRTUS INC.
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT TOTAL KNEE ARTHROPLASTY, STERILE TOURNIQUET CUFF FAILED. INFLATION TUBE CAME LOOSE AT CONNECTION TO CUFF 3 TIMES DURING PROCEDURE. DURING 3RD FAILURE PATIENT'S HR DROPPED TO 35 BPM WITH A HALF SCREEN AYSTOLE. PATIENT'S CARDIAC STATUS WAS STABILIZED, THE MALFUNCTIONING CUFF WAS REPLACED BY ANOTHER OF THE SAME TYPE, AND THE SURGICAL PROCEDURE WAS COMPLETED. NO ADVERSE OUTCOMES TO THE PT WERE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSAIRE TOURNIQUET, PNEUMATIC KCY VIRTUS INC. A70117011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other