BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 7752175 · Received August 6, 2018

    Report

    Report Number
    0001954182-2018-00045
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    January 11, 2018
    Report Date
    July 10, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). K081047; K123188; K133786. THE DEVICE WAS REPAIRED AND RETURNED. THE PRODUCT WAS EVALUATED BY AN EXTERNAL CONTRACTOR ON (B)(6) 2018. THE PREVIOUS REPAIR REPORT FOR ULTRA DUO FLEX FLUID CART SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR REPORT REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. USING A QUERY FOR SERIAL NUMBER (B)(4), THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED EIGHT TIMES, THE PREVIOUS REPAIR BEING FOR AN ISSUE WITH THE LEVEL SENSOR ON (B)(6) 2017. THE LEVEL SENSOR IS ASSOCIATED WITH THE CURRENT REPAIR. THUS, THIS REPAIR WAS A RELATED ISSUE. ON (B)(6) 2018, IT WAS REPORTED FROM (B)(6) CENTER THAT THIS UNIT HAD SENSOR ERRORS. ON (B)(6) 2018, (B)(6) SERVICES WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND FOUND THAT BOTH SENSORS WERE FLUCTUATING. HE REPLACED TWO LEVEL SENSORS (PART # 91584, LOT CODE 0026924) AND THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE CART TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT ISSUING SENSOR ERRORS WAS DUE TO A MALFUNCTIONING LEVEL SENSOR IN EACH CYLINDER. THE LEVEL SENSOR IS RESPONSIBLE FOR EVALUATING THE FLUID LEVELS IN THE CART CYLINDERS, AND A MALFUNCTIONING LEVEL SENSOR WOULD ISSUE SENSOR ERRORS. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE LEVEL SENSOR WAS REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS UNIT HAD SENSOR ERRORS. THE EVENT OCCURRED DURING CLEANING. EVALUATION OF THE DEVICE BY THE TECHNICIAN ARRIVED AT THE SITE AND FOUND THAT BOTH SENSORS WERE FLUCTUATING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593833 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1