BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3801883 · Received February 11, 2014

    Report

    Report Number
    1526350-2014-00078
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ZIMMER SURIGCAL
    Product Code
    KCY
    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 FOLLOW UP 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 ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90449 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET KCY ZIMMER SURIGCAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1