BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-NOX

    MDR report key: 8964424 · Received September 5, 2019

    Report

    Report Number
    8964424
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 9, 2019
    Report Date
    August 20, 2019
    Manufacturer
    CARESTREAM MEDICAL INTERNATIONAL LTD
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECENT INSTITUTION OF THE USE OF NITROUS OXIDE (NO) FOR LABORING MOTHERS WAS FOLLOWED BY BADGE TESTING TO MEASURE THE AMOUNTS OF NO IN 2 AREAS ON THE PATIENT ROOM AND THE EXPOSURE TO THE NURSE ATTENDING TO THE PATIENT. AN INDEPENDENT REPORT WAS RECEIVED INDICATING THAT 7 OF 18 READINGS EXCEEDED NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH) RECOMMENDATIONS OF 25PPM OF NO OVER THE DURATION OF THE EXPOSURE. THE PROGRAM WAS SUSPENDED THE FOLLOWING DAY. IT IS NOT CURRENTLY KNOWN IF THE EQUIPMENT USED CONTRIBUTED TO THESE EXPOSURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760872 PRO-NOX MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR CARESTREAM MEDICAL INTERNATIONAL LTD CMI-0100-PNX-HS

    Patients

    Seq Age Sex Outcome Treatment
    1