BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 2000 TOURNIQUET

    MDR report key: 2192750 · Received July 20, 2011

    Report

    Report Number
    1526350-2011-00155
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 ZIMMER ATS 2000 CUFF DEFLATED UNEXPECTEDLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE UNIT WAS FOUND TO NOT WORK DURING ROOM SET-UP. AN ALTERNATIVE AVAILABLE DEVICE WAS USED TO START AND COMPLETE THE PROCEDURE. THERE WAS NO DELAY REPORTED. THE DEVICE WAS SENT TO THE HOSPITAL'S SERVICE DEPARTMENT WHO PROVIDED THE FOLLOWING INFORMATION: LED MESSAGE: "NO, RED DEFLATE BUTTON NEEDED TO PRESS SEVERAL TIMES BEFORE IT WOULD WORK. DEVICE FILLED RED AND BLUE PART, EVEN IF THEY DIDN'T PRESS BUTTONS AT ALL. THE GAUGES IN THE PRESSURE READINGS WERE LOWER THAN IT SHOULD BE." THERE WAS NO RESPONSE TO REQUEST FOR CUFF AND HOSE(S) TO BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1