BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 7141877 · Received December 22, 2017

    Report

    Report Number
    0001954182-2017-00045
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 4, 2017
    Report Date
    January 9, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). PMA 510(K): K081047; K123188; K133786. THE PRODUCT WILL BE EVALUATED BY AN EXTERNAL CONTRACTOR. ONCE THE EVALUATION/INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. PRODUCT EVALUATED BY EXTERNAL CONTRACTOR.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). 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 CRM TO QUERY FOR SERIAL NUMBER (B)(4), THE DEVICE WAS NOTED TO HAVE BEEN PREVIOUSLY REPAIRED THREE TIMES, THE PREVIOUS REPAIR BEING FOR AN ISSUE WITH A VALVE PACK ON 16 NOVEMBER 2017. THE VALVE PACK IS NOT ASSOCIATED WITH THE CURRENT REPAIR. THUS, THIS REPAIR WAS A NON-RELATED ISSUE. ON (B)(6) 2017, IT WAS REPORTED FROM UNIVERSITY OF (B)(6) THAT A UNIT WAS LEAKING FROM BOTTOM OF CART. DAY MECHANICAL SYSTEMS, INC WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND CONFIRMED THAT THE LEVEL SENSOR WAS LEAKING. HE REPLACED THE LEVEL SENSOR (PART # 91584) AND THE SOUND INSULATION (PART # 70011) 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 AS PER CL ¿ REPAIR CART AND EVAC REV. 0. THE ROOT CAUSE FOR THE UNIT LEAKING FROM BOTTOM OF THE CART WAS DUE TO A LOOSE LEVEL SENSOR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS LEAKING FROM BOTTOM OF THE CART. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921701 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0019210

    Patients

    Seq Age Sex Outcome Treatment
    1