BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS 3000 TOURNIQUET SYSTEM

    MDR report key: 2161860 · Received July 8, 2011

    Report

    Report Number
    1526350-2011-00140
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 HOSPITAL HAD A PROBLEM WITH THE ATS 3000. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE UNIT WAS GIVING CONTINUOUS ALARM. DEVICE WAS IN USE WHEN A CONTINUOUS AUDIBLE ALARM STARTED, BUT NO LED DISPLAY. SET PRESSURE WAS MAINTAINED, AND THERE WAS NO HARM TO PT REPORTED. THE PROCEDURE TIME WAS INCREASED BY AN ESTIMATED 30 MIN., DUE TO REMOVAL OF TOURNIQUET, AND COMPLETION OF PROCEDURE WITHOUT THE USE OF THE TOURNIQUET UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1