BEUDAMED
    FDA Adverse Event Death Summary report: N

    B & F OXYGEN CANNULA

    MDR report key: 436751 · Received January 6, 2003

    Report

    Report Number
    1924066-2003-00001
    Event Type
    Death
    Date Received
    January 6, 2003
    Date of Event
    December 23, 2002
    Report Date
    January 6, 2003
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE NASAL PRONG WAS OCCLUDED AND NOT ALLOWING O2 THRU TO THE PT. PT WAS ON CANNULA FOR A COUPLE OF WEEKS ACCORDING TO HOME HEALTH, BEFORE THE SPOUSE NOTICED THAT THERE WAS A PROBLEM WITH THE CANNULA. PT WENT BACK INTO HOSPITAL AND WAS IN THE HOSPITAL FOR A WEEK TO 10 DAYS AND THEN CAME BACK OUT ONTO EQUIPMENT THAT HAD BEEN CHANGED OUT (TUBING AND MACHINE). PT PASSED AWAY SEVERAL DAYS LATER. CANNULA WAS RETURNED TO ALLIED. COMPANY CHECKED THE REST OF THE CASE AND WAS TOLD IT WAS JUST THE ONE UNIT. NO RETURN AUTHORIZATION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B & F OXYGEN CANNULA OXYGEN CANNULA CAT ALLIED HEALTHCARE PRODUCTS, INC. 33240 OR 33242 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization