BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3030874 · Received March 28, 2013

    Report

    Report Number
    1526350-2013-00159
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 3000 TOURNIQUET WAS OVER PRESSURE IN THE LEFT CHANNEL. ADDITIONAL CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE EVENT OCCURRED DURING A BIOMEDICAL TEST/CHECK OF THE EQUIPMENT. THERE WAS NO REPORT OF HARM, DELAY, INCREASED PROCEDURE TIME, OR MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128711 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1