BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3800572 · Received February 11, 2014

    Report

    Report Number
    1526350-2014-00076
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; 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 WAS LOSING PRESSURE. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90012 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1