BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 3871215 · Received April 16, 2014

    Report

    Report Number
    1526350-2014-00282
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 02/08/2011 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE DEVICE WAS NOT RETUNED TO ZIMMER SURGICAL FOR EVALUATION; THEREFORE, THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED. IT WAS STATED DURING PRODUCT RETRIEVAL THAT "THE UNIT WAS TESTED ADN IT WAS FOUND TO BE PROPER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED BLEED THROUGH WITH THE ATS 3000 TOURNIQUET. THE PRESSURE WAS INCREASED FROM 250MMHG TO 350MMHG AND STILL THERE WAS BLEEDING. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PT INJURY ASSOCIATED WITH THE REPORT AND NO ALTERNATE DEVICE WAS RETRIEVED FOR USE DURING THE SURGERY AND THE SURGERY WENT ON WITH SLIGHT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233509 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1