BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXAIR GRAB 'N GO VANTAGE

    MDR report key: 4755980 · Received May 6, 2015

    Report

    Report Number
    1000448358-2015-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 8, 2015
    Report Date
    May 5, 2015
    Manufacturer
    PRAXAIR HEALTHCARE SERVICES
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS SHIPPED BACK TO WESTERN (THE CONTRACT MANUFACTURER) UNDER (B)(4) AND WAS RECEIVED ON APRIL 15, 2015. THE INVESTIGATION BY WESTERN IS ONGOING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) MEDICAL CENTER, THAT A GRAB 'N GO VANTAGE OXYGEN UNIT DID NOT PROVIDE ENOUGH FLOW OXYGEN. THE UNIT WAS BEING USED ON A PATIENT THAT WAS IN TRANSPORT WITHIN THE HOSPITAL. THERE WAS NO INJURY TO THE PATIENT. ANOTHER GRAB 'N GO VANTAGE OXYGEN UNIT WAS OBTAINED AND USED TO ADMINISTER OXYGEN TO THE PATIENT DURING TRANSPORT. THE GRAB 'N GO VANTAGE IS A CLASS I VALVE INTEGRATED PRESSURE REGULATING DEVICE, WHICH IS INSTALLED INTO AN ALUMINIUM HIGH PRESSURE GASEOUS MEDICAL OXYGEN USP CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299297 PRAXAIR GRAB 'N GO VANTAGE REGULATOR, PRESSURE, GAS CYLINDER CAN PRAXAIR HEALTHCARE SERVICES OXM-AEGNGVTG 0864509632

    Patients

    Seq Age Sex Outcome Treatment
    1