BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN REGULATOR

    MDR report key: 11443 · Received February 11, 1994

    Report

    Report Number
    MW1000728
    Event Type
    Malfunction
    Date Received
    February 11, 1994
    Date of Event
    January 27, 1994
    Report Date
    February 1, 1994
    Manufacturer
    ERIE MFG. CO.
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IS ON HOME OXYGEN THERAPY VIA COMPRESSED GAS PORTABLE SYSTEM WITH REGULATOR. WHEN PT'S WIFE ATTEMPTED TO TURN FLOW REGULATOR KNOB ON, SHE STATES SHE HEARD SOMETHING FALL TO THE FLOOR. SHE REPORTED THAT OXYGEN WOULD NOT FLOW THROUGH THE REGULATOR. INSPECTION OF THE REGULATOR REVEALED THAT A SPRING CLIP ON THE END OF THE SHAFT WHICH CONTROLS THE LITER FLOW WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN REGULATOR CAX ERIE MFG. CO. 477

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR