BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS 1200 TOURNIQUET SYSTEM

    MDR report key: 2971730 · Received January 30, 2013

    Report

    Report Number
    1526350-2013-00038
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SIMMER SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 1200 WAS NOT KEEPING PRESSURE. 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
    41839 ATS 1200 TOURNIQUET SYSTEM ATS 1200 TOURNIQUET SYSTEM KCY SIMMER SURGICAL NA 1206EA18

    Patients

    Seq Age Sex Outcome Treatment
    1