BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMETER

    MDR report key: 818598 · Received February 7, 2007

    Report

    Report Number
    818598
    Event Type
    Malfunction
    Date Received
    February 7, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 7, 2007
    Manufacturer
    ALLIED HEALTH CARE PRODUCTS, INC.
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    ALLIED HEALTHCARE: TIMETER FLOW CONTROL: MODEL(S) 1500XX-XX SERIES ARE MEDICAL AIR FLOW CONTROLS AVAILABLE WITH O2 (OXYGEN)DISS (DIAMETER INDEX SAFETY SYSTEM)OUTPUT CONNECTORS. THIS ENABLES OFF THE SHELF OXYGEN (GREEN COLORED FITTINGS) TO BE MATED TO A MEDICAL AIR SUPPLY. HOW DOES THIS COMPLY WITH NFPA 99 9.3.2 "...LOW PRESSURE THREADED CONNECTORS SHALL BE IN ACCORDANCE WITH CGA STANDARD FOR NON INTERCHANGEABLE CONNECTIONS FOR MEDICAL GASES..."? IN ADDITION, ANOTHER MANUFACTURER'S MODEL(S) XXXX-XXXX-XXX ARE AVAILABLE THIS WAY. FURTHERMORE, GREEN AND YELLOW COLORED BARBED (CHRISTMAS TREE) FITTINGS ARE OFFERED TO MATE WITH DISS O2 MALE FITTINGS...MAKING IT STILL EASIER TO MIX UP MEDICAL AIR AND MEDICAL OXYGEN SUPPLIES. WE HAVE NOT RECIEVED A RESPONSE FROM THE CGA AND NO REASONABLE EXPLANATION FROM THE ORIGINAL EQUIPMENT MANUFACTURER'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMETER FLOWMETER, MEDICAL AIR CAX ALLIED HEALTH CARE PRODUCTS, INC. 1500XX-XX SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR