BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3241106 · Received July 18, 2013

    Report

    Report Number
    1526350-2013-00393
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MFG ON 09/17/2012 AND HAS NO PREVIOUS REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED NO FAILURES AND THE DEVICE MET FUNCTIONAL SPECIFICATIONS. THE CAUSE OF THE REPORTED ISSUE IS UNK. THE DEVICE WAS RECALIBRATED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 3000 TOURNIQUET HAD OVER PRESSURE ON ONE SIDE, AND IT RAN BUT THERE WAS A BAD CONTACT. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADD'L INFO WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335574 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1