BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO CART WITH SMOKE EVAC

    MDR report key: 7875477 · Received September 13, 2018

    Report

    Report Number
    0001954182-2018-00061
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 24, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PREVIOUS REPAIR RECORD FOR ULTRA DUO FLEX FLUID CART SERIAL NUMBER 132957 WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR RECORD 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 BY ZIMMER BIOMET SURGICAL 2 TIMES. THE LAST REPAIR FOR THIS CART WAS DONE FOR VALVE PACK ISSUE AND IT IS NOT RELATED TO THE CURRENT REPAIR. ON 14 AUGUST 2018, IT WAS REPORTED FROM UNIVERSITY OF IOWA THAT UNIT WAS NOT READING FLUID LEVEL PROPERLY ON EITHER SIDE. THE SERVICE TECHNICIAN FROM DAY MECHANICAL SYSTEMS ARRIVED AT THE SITE ON 16 AUGUST 2018, EVALUATED THE UNIT FOR REPORTED EVENT AND CONFIRMED THAT THE FLUID LEVELS ON BOTH CYLINDER #1 AND #2 WERE NOT READING CORRECTLY. AFTER THAT SERVICE TECHNICIAN REPLACED LEVEL SENSORS ON BOTH THE CYLINDERS AND CONFIRMED THAT UNIT WAS FUNCTIONING AS INTENDED. THE SERVICE TECHNICIAN THEN RETURNED THE UNIT BACK TO SERVICE WITHOUT ANY FURTHER CONCERNS. THE UNIT WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT ISSUING LEVEL SENSOR ERROR WAS DUE TO A MALFUNCTIONING LEVEL SENSOR. THE LEVEL SENSOR IS RESPONSIBLE FOR MEASURING THE FLUID LEVELS IN THE CART, AND A MALFUNCTIONING LEVEL SENSOR WOULD CAUSE THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). COMMON DEVICE NAME: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED. PMA/510K NUMBER: K081047; K123188; K133786. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ULTRA DUO HIGH FLUID CART WAS NOT READING FLUID LEVEL PROPERLY ON EITHER SIDE. THE EVENT TIMING IS UNKNOWN. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715258 ULTRAFLEX DUO CART WITH SMOKE EVAC SEE H10 JCX DORNOCH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1