BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHEMETRON

    MDR report key: 10365251 · Received August 4, 2020

    Report

    Report Number
    1924066-2020-00001
    Event Type
    Death
    Date Received
    August 4, 2020
    Date of Event
    July 19, 2020
    Report Date
    July 28, 2020
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    BXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOWMETER WAS MOST LIKELY MANUFACTURED IN THE EARLY 1980S AS WE CANNOT DETERMINE THE EXACT DATE OF MANUFACTURE. THE COLOR CODING STANDARD WAS NOT ESTABLISHED UNTIL 1988 (NFPA 99 5.1.11 - LABELING AND IDENTIFICATION - SEE TABLR 5.1.11) AND THUS DID NOT HAVE THE COLOR DEMARCATION. THE MODEL AND CATALOG NUMBER IS BELIEVED TO BE 34-01-0136. THE LABEL ON THE PRODUCT MAY HAVE BEEN DATE STAMPED WITH THE DATE OF MANUFACTURE. WE HAVE NOT RECEIVED THE PRODUCT FOR EVALUATION. THIS PRODUCT HAS NOT BEEN MANUFACTURED FOR 25 TO 30 YEARS AND HAS AN EXPECTED LIFE OF 10 YEARS. THE FLOWMETER IN QUESTION WAS MOUNTED BY THE USER TO A GAS DISTRIBUTION BAR THAT ALLOWED MULTIPLE ITEMS TO BE CONNECTED TO A SINGLE SUPPLY GAS HOSE. THE SUPPLY GAS HOSE WAS A YELLOW AIR HOSE. CONNECTED TO THIS NOW AIR DISTRIBUTION BAR WAS AN AIR OUTLET WITH A YELLOW BUTTON LABELED "AIR", AN "AIR" DISS FITTING AND THE FLOWMETER IN QUESTION WHICH WAS LABELED "AIR", BUT, HAD A BLACK KNOB. THE USER STATES THAT CONFUSION WAS CAUSED BECAUSE THEY MISTOOK THE FLOWMETER FOR OXYGEN BECAUSE OF THE BLACK COLORED KNOB. THE BLACK COLOR BY STANDARD IS NITROGEN. PATIENTS ARE NEVER GIVEN NITROGEN FOR RESUSCITATION AS THIS WOULD KILL THEM. CARE GIVERS ARE TRAINED THAT OXYGEN IS GREEN, AIR IS YELLOW, VACUUM IS WHITE, NITROGEN IS BLACK, NITROUS OXIDE IS BLUE, AND SO FORTH. OUR INITIAL ASSESSMENT IS THAT THE USER IN HASTE MADE AN ERROR WHEN CONNECTING THE BAG MASK RESUSCITATOR TO THE AIR FLOWMETER. WE HAVE NOT RECEIVED PICTURES OF THE SITE THIS EVENT HAPPENED TO SEE IF IN FACT AN OXYGEN FLOWMETER WAS PRESENT AND CLEARLY MARKED. THIS IS A PRELIMINARY INVESTIGATION AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. IT WAS DETERMINED DURING THE CODE THAT THE RESUSCITATION BAG USED FOR VENTILATION WAS CONNECTED TO A MEDICAL AIR FLOWMETER INSTEAD OF AN OXYGEN FLOWMETER. THE AIR FLOWMETER DID NOT HAVE STANDARD YELLOW DEMARCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829992 CHEMETRON AIR FLOWMETER BXY ALLIED HEALTHCARE PRODUCTS, INC. 15002-13

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR