BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHEMETRON TIRO OXYGEN OUTLET STATION

    MDR report key: 2625837 · Received June 11, 2012

    Report

    Report Number
    1924066-2012-00005
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 11, 2012
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TRIO OUTLET STATIONS WERE LAST MADE IN 1996. THEREFORE THE TRIO OUTLET STATION IS AT LEAST 16 YEARS OLD. THE TRIO OUTLET STATION WAS PLACED IN THE OPENING UPSIDE DOWN. THIS IS INDICATED BY THE LABELING, IN THE PICTURE, BEING UPSIDE DOWN ON THE FACEPLATE. THE FACEPLATE IS STICKING OUT BECAUSE THE KEYING PIN WOULD NOT LET IT LATCH PROPERLY. HOSPITAL VENTILATORS GENERALLY HAVE OXYGEN METERS AND LOW OXYGEN ALARMS. APPARENTLY THESE WERE NOT CHECKED AFTER ATTACHING THE PT TO THE VENTILATOR. THE TRIO OUTLET STATIONS WERE A UNDERWRITERS LABORATORIES LISTED PRODUCT AT THE TIME OF MANUFACTURING. THE UNIT INVOLVED HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS INTUBATED AND PLACED ON A VENTILATOR. WITHIN MINUTES HE BECAME CYANOTIC AND BRADYCARDIC AND CODE 89. CALLED PHYSICIAN. PT WAS BAGGED AND HE RETURNED TO BASELINE. NEW VENTILATOR WAS PLACED ON PT AND RECEIVED LOW OXYGEN ALARM. IT WAS IMMEDIATELY NOTICED THAT THE OXYGEN CONNECTION FACEPLATE WAS NOT SECURE AND WAS UPSIDE DOWN IN THE WALL. THIRD VENTILATOR WAS HOOKED UP TO A DIFFERENT OXYGEN FACEPLATE AND WE HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMETRON TIRO OXYGEN OUTLET STATION OXYGEN OUTLET STATION CAN ALLIED HEALTHCARE PRODUCTS, INC. 88-47-3601

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other