BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 7200829 · Received January 17, 2018

    Report

    Report Number
    0001954182-2018-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    January 12, 2018
    Report Date
    March 16, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PK162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ON 10 JANUARY 2018, (B)(4) 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 UNIT WAS LEAKING, AND NOTED THAT THE UNIT WAS NOT CONNECTING TO THE EVAC STATION PROPERLY. THE TECHNICIAN REPLACED THE RECEIVER DRAINED THE CONDENSATION TUBE, AND THEN VERIFIED THAT THE UNIT WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE UNIT TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. THE ROOT CAUSE FOR THE UNIT LEAKING FORM THE BOTTOM WAS DUE TO FLUID IN THE CONDENSATION TUBE. THE CONDENSATION TUBE IS TO ALLOW THE STEAM FROM THE HOT WATER IN THE CART TO ESCAPE DURING PROCESSING, AND THIS STEAM CAN CONDENSE AND COLLECT IN THE CONDENSATION TUBE. THIS CAN GIVE THE APPEARANCE OF A LEAK. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CONDENSATION TUBE WAS DRAINED. 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

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THE PRODUCT WILL BE EVALUATED BY AN EXTERNAL CONTRACTOR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT WAS LEAKING FROM THE BOTTOM. ADDITIONAL INFORMATION CLARIFIED THAT THE EVENT OCCURRED DURING SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45139 DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0023808

    Patients

    Seq Age Sex Outcome Treatment
    1