BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 7183254 · Received January 11, 2018

    Report

    Report Number
    0001954182-2018-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 15, 2017
    Report Date
    January 11, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PMA 510(K): K081047; K123188; K133786. THE DEVICE HISTORY RECORD (DHR) REVIEW FOR ULTRA DUO FLEX FLUID CART NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2017, IT WAS REPORTED FROM COMMUNITY HOSPITAL THAT THE UNIT WAS LEAKING. ACCOUNT PULLED THE LEVEL SENSOR AND FOUND THAT THE O-RING HAS FAILED. ACCOUNT ORDERED THE LEVEL SENSOR AND THEY WOULD REPLACE IT BY THEMSELVES ONCE RECEIVED. WORK ORDER WAS CLOSED. NO REPAIR CHECKLIST WAS REQUIRED AS PER CRM. THE SERVICE TECHNICIAN NEVER VISITED SITE TO VERIFY THE REPORTED EVENT AS THE ACCOUNT ORDERED AND REPLACED BY ACCOUNT HIMSELF. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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. THE EVENT OCCURRED DURING CLEANING BUT WAS FIRST NOTICED DURING SURGERY. THE CART ALSO HAD A STRANGE ODOR DURING THE CASE, UPON REMOVING COVERS, EVIDENCE OF BODILY FLUIDS LEAKING ON TO COMPRESSOR AND INTO BOTTOM OF CART WAS FOUND. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26618 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1