BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 750 TOURNIQUET SYSTEM (ENGLISH)

    MDR report key: 3030888 · Received March 28, 2013

    Report

    Report Number
    1526350-2013-00157
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 750 ALARMED VALVE FAIL, AND DEFLATED DURING USE. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129685 ATS 750 TOURNIQUET SYSTEM (ENGLISH) ATS 750 TOURNIQUET SYSTEM KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1