BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIMETER

    MDR report key: 906498 · Received March 5, 2007

    Report

    Report Number
    1924066-2007-00002
    Event Type
    Other
    Date Received
    March 5, 2007
    Date of Event
    February 7, 2007
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC.
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIR FLOW METERS IN QUESTION DO HAVE OXYGEN DISS FITTINGS ON THE BOTTOM. HOWEVER, IT HAS BEEN COMMON PRACTICE TO USE OXYGEN DISS FITTINGS ON THE BOTTOM OF AIR FLOW METERS BECAUSE MOST OF THE EQUIPMENT THAT YOU WOULD ATTACH TO THE FLOW METER COMES WITH OXYGEN DISS FITTINGS. THIS INCLUDES ITEMS SUCH AS HUMIDIFIERS, PLASTIC BARBS (CHRISTMAS TREE FITTINGS), MASK, AND CANNULA WHICH HAVE THREADED FITTINGS ON THE END, ETC. THE FLOW METERS IN QUESTION GENERALLY HAVE AIR INLET FITTINGS AND ARE LABELED AND COLOR CODED FOR AIR. ONCE YOU SCREW A HOSE BARB ADAPTER ON THE BOTTOM OF THE FLOW METER, YOU MUST READ THE LABEL ON THE FLOW METER OR THE OUTLET STATION TO DETERMINE WHAT GAS YOU ARE CONNECTING THE PT TUBING TO. AIR FLOW METERS WITH OXYGEN DISS FITTINGS ARE BEING MADE BY MOST OF THE MAJOR FLOW METER MFRS IN THE INDUSTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; EVENT DESC: ALLIED HEALTHCARE: TIMETER FLOW CONTROL: MODEL(S) 1500X-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 OHMEDA MEDICAL MODEL(S) 6700-XXXX-XXX ARE AVAILABLE THIS WAY. FURTHER MORE 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 RECEIVED A RESPONSE FROM CGA AND NO REASONABLE EXPLANATION FROM THE OEM'S. OTHER IN 2007, RESEARCHED ON LINE SPEC. SHEETS AND DISCUSSED WITH OEM'S. PHYSICALLY MOUNTED A MEDICAL OXYGEN BARBED FITTING TO A MEDICAL AIR FLOW METER THAT WAS PURCHASED WITH AN OXYGEN DISS CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMETER FLOW METER CAX ALLIED HEALTHCARE PRODUCTS INC. 1500X-XX SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1