BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 2000 TOURNIQUET

    MDR report key: 1920906 · Received November 8, 2010

    Report

    Report Number
    1526350-2010-00163
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    KCY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 2000 MACHINE STARTED PUMPING/INFLATING ON ITS OWN. ADD'L CLINICAL F/U REC'D ON (B)(6) 2010 INDICATED THAT THE UNIT WAS NOT IN PT USE. THE NURSE TURNED ON THE UNIT FOR ROOM SET-UP AND THE UNIT WENT IN TO INFLATION MODE. NO CUFF WAS ATTACHED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 2000 TOURNIQUET ATS 2000 TOURNIQUET KCY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1