BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 750 TOURNIQUET SYSTEM (ENGLISH)

    MDR report key: 3040303 · Received April 3, 2013

    Report

    Report Number
    1526350-2013-00164
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 7 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2012. UPON INITIAL INSPECTION, IT WAS DISCOVERED THAT THE DEVICE FUNCTIONED NORMALLY. THE CUSTOMER DID NOT RETURN THE CUFF THAT WAS USED DURING THE SURGERY. A CUFF THAT DISPLAYED A LEAK COULD HAVE CAUSED THE CUSTOMER'S EVENT. CUSTOMER'S EVENT COULD NOT BE DUPLICATED AND THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 750 TOURNIQUET SYSTEM COMPLETELY STOPPED. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE ATS UNIT TURNED OFF DURING A SURGICAL PROCEDURE AND THE SET PRESSURE WAS NOT MAINTAINED. THE CUSTOMER RETURNED INFO THAT THERE HAD BEEN NO HARM TO THE PT, NO RELEASE OF I.V. LOCAL ANESTHESIA, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE AVAILABLE UNIT. THE CUFF IN USE WAS IDENTIFIED AS A ZIMMER 18" SINGLE PORT, RE-USABLE CUFF, BUT THE CUSTOMER INDICATED THE CUFF WAS NOT ABLE TO BE RETURNED FOR INCLUSION IN THE INVESTIGATION OF THE REPORTED EVENT. THE PROCEDURE TIME WAS STATED TO HAVE BEEN INCREASED BY FIFTEEN (15) MINUTES WITH NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136936 ATS 750 TOURNIQUET SYSTEM (ENGLISH) ATS 750 TOURNIQUET SYSTEM (ENGLISH) KCY ZIMMER SURGICAL NA DD060175

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER 18" SINGLE PORT| RE-USABLE CUFF