BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS3000 TOURNIQUET SYSTEM

    MDR report key: 8018938 · Received October 30, 2018

    Report

    Report Number
    0001526350-2018-00977
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    KCY
    PMA / PMN Number
    K050411
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL/ FINAL REPORT TO RELAY ADDITIONAL INFORMATION, REGARDING A DEVICE MALFUNCTION DISCOVERED DURING PRODUCT INVESTIGATION. CONCLUSION SUMMARY: ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE HAD A BATTERY FAILURE. THE CUSTOMER RETURNED AN A.T.S. 3000 TOURNIQUET DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED A.T.S. 3000TS TOURNIQUET SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE A.T.S. 3000 TOURNIQUET BY MEDICREA ON AUGUST 3, 2018 REVEALED THAT THE BATTERY WAS OUT OF SERVICE. THE SWITCH WAS IN BAD CONDITION AND THERE WAS A LEAK ON THE MAIN PORT. REPAIR OF THE A.T.S. 3000 TOURNIQUET WAS PERFORMED BY MEDICREA ON OCTOBER 15, 2018 WHICH INCLUDED REPLACEMENT OF THE BATTERY AND MEMBRANE I/O SWITCH. A.T.S. 3000 TOURNIQUET, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE BATTERY WAS OUT OF SERVICE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE BATTERY WAS OUT OF SERVICE. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE SURGERY, THE ATS BATTERY FAILED AND WOULD NOT CHARGE. INVESTIGATION REVEALED THAT THE SWITCH WAS IN BAD CONDITION AND THERE WAS A LEAK ON THE MAIN PORT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860541 ATS3000 TOURNIQUET SYSTEM TOURNIQUET, PNEUMATIC KCY ZIMMER SURGICAL, INC. 61445646

    Patients

    Seq Age Sex Outcome Treatment
    1