BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 1200 TOURNIQUET SYSTEM

    MDR report key: 2181261 · Received July 8, 2011

    Report

    Report Number
    1526350-2011-00142
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SVC RECORDS INDICATE THAT THE DEVICE IS 8 YEARS OLD AND HAS BEEN RETURNED FOR REPAIR PREVIOUSLY. THE PUMP ON THE ATS 1200 IS SUCH THAT IT WILL MAINTAIN PRESSURE IN ALL BUT A CATASTROPHIC PRESSURE LOSS, SUCH AS A LARGE CUFF RUPTURE. THIS DOES NOT APPEAR TO BE THE CASE WITH THIS COMPLAINT. CLINICAL F/U DID NOT INDICATE AN AUDIBLE ALARM SOUNDED, WHICH WOULD BE THE CASE IF A GREATER THAN 15MMHG OF PRESSURE WAS LOST. THE HOSPITAL STAFF ALSO STATED "THE CUFF WAS MOST LIKELY PUT ON IMPROPERLY BY A TRAVELER STAFF." THIS IS A MORE LIKELY SCENARIO THAT THE CUFF WOULD MOVE, CAUSING A TEMPORARY PRESSURE LOSS, THEN INFLATING TO MAINTAIN THE SET PRESSURE. THE CUFF WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 1200 "LET GO OF PRESSURE DURING CASE." ADDITIONAL CLINICAL F/U WITH THE HOSPITAL INDICATED THAT "THE TOURNIQUET CUFF MOST LIKELY WAS PUT ON IMPROPERLY BY TRAVELER STAFF WHO WERE NO LONGER AT THE FACILITY." THERE WAS REPORT OF SOME BLOOD IN THE FIELD BUT NOT MUCH. THERE WAS NO REPORTED HARM TO THE PT OR ADDITIONAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 1200 TOURNIQUET SYSTEM ATS 1200 TOURNIQUET SYSTEM KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1