BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS 1200 W/HOSES, W/ENGLISH MANUAL

    MDR report key: 7587670 · Received June 11, 2018

    Report

    Report Number
    0001526350-2018-00541
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    April 20, 2018
    Report Date
    June 11, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    KCY
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION SUMMARY: ON (B)(6) 2018, IT WAS REPORTED THAT THE DEVICE HAD A LOW BATTERY. THE CUSTOMER RETURNED AN A.T.S. 1200 TOURNIQUET DEVICE, SERIAL (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR REPORT REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR AND PREVIOUS REPAIR REPORT REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS PREVIOUSLY REPAIRED/EVALUATED A.T.S. 1200 TOURNIQUET SERIAL (B)(4) ONE TIME AS DOCUMENTED IN THE VDOC SERVICE PORTAL. THE LAST REPAIR WAS NOVEMBER 28, 2017 WHERE IT WAS REPORTED THAT THERE WAS A FUNCTIONAL DEFECT AND THE BATTERY AND CONTROL PANEL WERE REPLACED. THIS IS NOT A RELATED ISSUE. PRODUCT REVIEW OF THE A.T.S. 1200 TOURNIQUET BY MEDICREA ON MAY 14, 2018 REVEALED THAT THE BATTERY VOLTAGE WAS LOW AND THE BATTERY WAS DEFECTIVE. REPAIR OF THE A.T.S. 1200 TOURNIQUET HAS NOT YET BEEN PERFORMED BY MEDICREA AS THE QUOTE FOR SERVICE IS STILL PENDING CUSTOMER APPROVAL. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE BATTERY VOLTAGE WAS LOW AND THE BATTERY WAS DEFECTIVE. 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 VOLTAGE WAS LOW AND THE BATTERY WAS DEFECTIVE. 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 THE DEVICE GAVE FUNCTIONAL DEFECT "LOW BATTERY" ERROR. A GREATER THAN 15 MINUTE DELAY WAS REPORTED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428969 ATS 1200 W/HOSES, W/ENGLISH MANUAL TOURNIQUET, PNEUMATIC KCY ZIMMER SURGICAL, INC. N/A 60181420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other