BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLIED OXYGEN REGULATOR

    MDR report key: 278783 · Received May 16, 2000

    Report

    Report Number
    1924066-2000-00003
    Event Type
    Death
    Date Received
    May 16, 2000
    Date of Event
    April 11, 2000
    Report Date
    May 16, 2000
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CAN
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT REPORTED TO ALLIED WAS AS FOLLOWS: AN INTUBATED PT WAS INADVERTENTLY CONNECTED TO THE UNREGULATED OUTPUT OF AN OXYGEN REGULATOR ON A SMALL OXYGEN BOTTLE VIA A JACKSON-REESE TUBING SET. THE PT WAS SUPPOSED TO BE CONNECTED TO THE REGULATED (0-25 LPM) OUTPUT. REGULATOR HAD SIMILAR THREADED CONNECTORS FOR BOTH THE REGULATED AND UNREGULATED OUTPUTS. BECAUSE THE OXYGEN FLOWOUT OF THE UNREGULATED CONNECTOR GREATLY EXCEEDED 25 LPM, THE PT SUFFERED A PNEUMOTHORAX AS A RESULT. THE INCIDENT REVEALED THAT ANY REGULATOR HAVING INTERCHANGEABLE OUTPUT CONNECTORS FOR BOTH REGULATED (UP TO 25 LPM) AND UNREGULATED (50 PSI) OUTPUTS CREATES AN UNACCEPTABLE RISK OF THE WRONG CONNECTOR BEING USED. THE REGULATOR IN THIS INCIDENT HAS A "DISS" MALE REGULATED OUTLET AND A "DISS" CHECK VALVE FOR THE UNREGULATED OUTPUT. THE "DISS" FITTING FOR THE REGULATED OUTPUT WAS MISSING, WHICH CONTRIBUTED TO THE USER INADVERTENTLY CONNECTING THE THERAPEUTIC TUBING ON THE UNREGULATED CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIED OXYGEN REGULATOR OXYGEN REGULATOR CAN ALLIED HEALTHCARE PRODUCTS, INC. 32-29-5204 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *