BEUDAMED
    FDA Adverse Event Death Summary report: N

    TIMETER OXYGEN FLOWMETER

    MDR report key: 20888602 · Received December 10, 2024

    Report

    Report Number
    1924066-2024-00130
    Event Type
    Death
    Date Received
    December 10, 2024
    Date of Event
    June 22, 2023
    Report Date
    November 25, 2024
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS INC.
    Product Code
    CAX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FLOWMETER WAS ORDERED AND SOLD WITHOUT AN INLET ADAPETER, BECAUSE SOME FOREIGN COUNTRIES NEED SPECIFIC ADAPTERS TO BE COMPATIBLE WITH THE OUTLET STATIONS THEY USE IN THEIR COUNTRIES. THE INSTRUCTIONS SHEET THAT IS SHIPPED IWH TEACH FLOWMETERS STATES "DO NOT MIX GASES". THIS FLOWMETER WAS LABELD AND COLOR CODED FOR USE IWTH OXYGEN. NO WHERE WAS THERE ANY INDICATION IT WAS OK TO USE IT WITH NITOUS OXIDE. CUSTOMER MODIFIED THE FLOWMETER AND DID NOT VERIFY MODIFICATION WAS CORRECT BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED : THE CUSTOMER ATTACHED A NITROUS OXIDE ADAPTER TO THE INLET OF THE OXYGEN FLOWMETER. THE FLOWMETER WITH THE N2O ADAPTER WAS ATTACHED TO A NITROUS OXIDE OUTLET STATION AND TURNED ON. THE PATIENT WAS GIVEN 100% NITROUS OXIDE AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679369 TIMETER OXYGEN FLOWMETER OXYGEN FLOWMETER CAX ALLIED HEALTHCARE PRODUCTS INC. 15001-03 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death