BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXAIR GRAB-N-GO III MEDICAL OXYGEN SYSTEMS

    MDR report key: 524940 · Received May 14, 2004

    Report

    Report Number
    524940
    Event Type
    Malfunction
    Date Received
    May 14, 2004
    Date of Event
    March 1, 2004
    Report Date
    April 1, 2004
    Manufacturer
    PRAXAIR, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WITH SEVERE PULMONARY HYPERTENSION RELATED TO CONGENTIAL LUNG HYPOPLASIA AND LIMITED PULMONARY CIRCULATION. PT WAS BEING SEEN IN THE PEDIATRIC SPECIALTY CLINIC AND BECAME APNEIC. A PHYSICIAN RESPONDED TO THE NURSE'S CALL FOR HELP, AND A CODE WAS CALLED. DURING THE CODE, THE PORTABLE OXYGEN TANK FAILED TO DELIVER OXYGEN. [THERE WAS NO HARM TO THE PT. THE STAFF GRABBED ANOTHER TANK QUICKLY. NO FLOW COULD BE HEARD. BIOMED DID NOT LOOK AT THE DEVICE AFTER THE INCIDENT. BUT THE DISTRIBUTOR WAS CALLED AND FOLLOW UP ANALYSIS FROM THEM IS EXPECTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRAXAIR GRAB-N-GO III MEDICAL OXYGEN SYSTEMS PORTABLE MEDICAL OXYGEN SYSTEM CAN PRAXAIR, INC. PRX-9369 *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other