BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3000135 · Received February 14, 2013

    Report

    Report Number
    1526350-2013-00067
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 2 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2012. OBSERVATION OF THE UNIT REVEALED THAT IT FUNCTIONED PROPERLY ON AC AND DC. NO LEAKS WERE OBSERVED AND THE MOTOR OF THE UNIT DID NOT RUN CONSTANTLY AS REPORTED. THE DEVICE MET ALL FUNCTIONAL STANDARDS. THE ASSOCIATED CUFF WAS NOT RETURNED WITH THE DEVICE. A MINOR LEAK IN THE CUFF COULD HAVE CAUSED THE OBSERVED ISSUE. HOWEVER, IT CANNOT BE VERIFIED SINCE IT WAS NOT RETURNED. CAUSE OF CUSTOMER'S COMPLAINT COLD NOT BE DETERMINED AS IT WAS NOT DUPLICATED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE DROPS ON THE ZIMMER ATS 3000 THEN PICKS BACK UP. THE MOTOR SOUNDS LIKE IT IS CONTINUOUSLY RUNNING. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64608 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1