BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

    MDR report key: 7351341 · Received March 19, 2018

    Report

    Report Number
    0001954182-2018-00020
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 19, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).PMA/510(K): K081047; K123188; K133786. THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE IT WAS REPORTED FROM (B)(6) HOSPITAL THAT A UNIT WAS SETTING OFF THE OR ELECTRICAL PANEL ALARM WITH LEAKAGE >1000MA. ON 27 FEBRUARY 2018, REPLITE WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND FOUND CURRENT LEAKAGE CAUSED BY DAMAGED FAN THAT WAS DAMAGED FROM A VALVE PACK LEAK. HE REPLACED THE FAN RESEATED THE VALVE PACK, 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 SETTING OFF THE OR ELECTRICAL PANEL ALARM WAS DUE TO CURRENT LEAKAGE FROM A DAMAGED FAN, WHICH WAS CAUSED BY A LEAKING VALVE PACK. FLUID WOULD DAMAGE THE ELECTRICAL CIRCUITS OF THE FAN UNIT, LEADING TO CURRENT LEAKAGE, WHICH IN TURN WOULD TRIP THE ELECTRICAL PANEL ALARM. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE VALVE PACK WAS RESEATED AND THE FAN WAS REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. EVALUATED BY EXTERNAL SERVICE TECHNICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRA DUO HIGH FLUID CART WAS SETTING OFF THE OR ELECTRICAL PANEL. IT STATED THAT FLUID WAS LEAKING DURING SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191118 ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1