BEUDAMED
    FDA Adverse Event Summary report: N

    ACCUTRON

    MDR report key: 430489 · Received December 2, 2002

    Report

    Report Number
    MW1026863
    Date Received
    December 2, 2002
    Date of Event
    October 1, 2002
    Report Date
    November 19, 2002
    Manufacturer
    ACCUTRON
    Product Code
    KHA
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED IN THE OFFICE WITH A N2O-O2 UNIT THAT WAS RECENTLY INSTALLED. THE PIPES WERE CROSSED IN THE WALLS. DENTIST WAS GIVING PATIENTS 100% N2O WHEN THEY THOUGHT THEY WERE GIVING THEM 100% O2. THE PROBLEM WAS COMPOUNDED BY THE USE OF A FLAVORED MASK. THE SCENT INTERFERED WITH THE CHARACTERISTIC ODOR OF N2O. DENTIST COULD NOT SMELL THE ODOR OF N2O. THEY COULD ONLY SMELL THE SCENT FROM THE FLAVORED MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTRON NASAL HOOD WITH SCENTS KHA ACCUTRON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *