BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN

    MDR report key: 2142244 · Received June 9, 2011

    Report

    Report Number
    2142244
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    March 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    *
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TOURNIQUET MACHINE FAILURE IN THE MIDDLE OF THE PROCEDURE. THE TOURNIQUET WAS DETERMINED STILL INFLATED AND ALL TUBING CONNECTIONS CHECKED AND FOUND NOT TO BE THE PROBLEM. SURGEON STATED NOT TO TURN OFF THE MACHINE OR TO SWITCH OUT. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN TOURNIQUET MACHINE KCY * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR