BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGEX POST VALVE

    MDR report key: 855302 · Received May 23, 2007

    Report

    Report Number
    1924066-2007-00004
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    April 22, 2007
    Report Date
    May 22, 2007
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE FIRE INDICATES THE FIRE STARTED AFTER THE CYLINDER POST VALVE WAS TURNED ON AND THE REGULATOR WAS BEING ADJUSTED BETWEEN THE TWO PIECES AT THE PLASTIC WASHER. FDA SENT OUT A NOTIFICATION: OXYGEN REGULATOR FIRES RESULTING FROM INCORRECT USE OF CGA 870 SEAL ON 6-19-2006.

    Description of Event or Problem · 1

    FIRE DEPARTMENT HAD A FIRE ON ONE OF THEIR AMBULANCES. THE FIRE WAS BETWEEN THE PURITAN BENNETT OXYGEN REGULATOR AND THE SURGEX POST VALVE ON THE OXYGEN CYLINDER. THE POST VALVE HAD BEEN TURNED ON AND THEY WERE ADJUSTING THE LPM SETTING WHEN THE FIRE STARTED. NO ONE WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGEX POST VALVE POST VALVE ECX ALLIED HEALTHCARE PRODUCTS, INC. 31-11-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR