BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®)

    MDR report key: 25123042 · Received May 8, 2026

    Report

    Report Number
    0001526350-2026-00552
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    KCY
    PMA / PMN Number
    K123553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER CMP-1041310. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN - EVENT OCCURRED IN CANADA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE TOURNIQUET WAS NOT KEEPING PRESSURE. THE PRESSURE WAS SET AT 300 MMHG BUT DID NOT KEEP PRESSURE, IT WAS ALL OVER THE PLACE. THE PRESSURE WAS NOT WITHIN THE ACCEPTABLE RANGE FOR THE UNIT. THERE WAS NO PATIENT IMPACT. THERE WAS NO MEDICAL INTERVENTION. THERE WAS NO SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514343 A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®) TOURNIQUET, PNEUMATIC KCY ZIMMER SURGICAL, INC. 65795822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown