BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GNG (GRAB `N GO) OPTI E-CYLINDER

    MDR report key: 8896376 · Received August 15, 2019

    Report

    Report Number
    8896376
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 22, 2019
    Manufacturer
    PRAXAIR DISTRIBUTION, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE OPTI E-OXYGEN CYLINDERS HAVE BEEN FOUND WITH MALFUNCTIONING DIALS THROUGHOUT THE INSTITUTION. THE CURRENT DESIGN FLAW OF THE DIAL ALLOWS FOR A 360-DEGREE ROTATION ON CERTAIN CYLINDERS INSTEAD OF STOPPING AT OFF AND AUX. WHEN DIAL IS TURNED PAST THE OFF POSITION OR PAST THE AUX POSITION, THE DIAL BECOMES STUCK AT VARIOUS INTERVALS (1.5 LPM, 8 LPM) OR NO FLOW IS DETECTED FROM THE NIPPLE ADAPTER. MALFUNCTIONING CYLINDERS NEEDED TO BE REMOVED FROM THE PATIENT CARE AREAS CAUSING DELAYS IN PATIENT TRANSFERS. MANUFACTURER RESPONSE FOR OXYGEN CYLINDER, GNG OPTI E-CYLINDER (PER SITE REPORTER). PRAXAIR IS ACTIVELY ENGAGED WITH THE MANUFACTURER TO GET THE APPROVED ENGINEERING SOLUTION IMPLEMENTED ON NEW UNITS AS WELL AS A FIELD RETROFIT PLAN IN PLACE. THIS RESPONSE IS MONTHS FOLLOWING ORIGINAL NOTIFICATION TO PRAXAIR OF DEVICE FAILURE. PRAXAIR HAS ISSUED A FIELD NOTIFICATION TO ALL OF OUR REGIONAL SITES TO ALERT THEM TO THE CONDITION AND PROVIDE GUIDANCE ON INSPECTION OF UNITS. LOCAL LOCATION IS INSPECTING 100% OF UNITS BEING DELIVERED ON LOAD TO THE DELIVERY CARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691322 GNG (GRAB `N GO) OPTI E-CYLINDER REGULATOR, PRESSURE, GAS CYLINDER CAN PRAXAIR DISTRIBUTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1