BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA - OHIO DELUXE NEBULIZER HEATER

    MDR report key: 262617 · Received February 9, 2000

    Report

    Report Number
    1121732-2000-00001
    Event Type
    Injury
    Date Received
    February 9, 2000
    Date of Event
    December 13, 1999
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    CCQ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN INFANT WAS PLACED ON NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE. UPON ARRIVAL IN NICU RESPIRATORY THERAPIST STARTED HEATER. AFTER 1.5 HRS, THE RESPIRATORY THERAPIST NOTED THE INFANT'S NOSE WAS RED. THE INFANT'S NASAL SEPTUM WAS BURNED. ACCORDING TO CUSTOMER, THIS WAS THE RESULT OF A USER ERROR. THE NORMAL HOSP PROTOCOL IS TO HAVE THE HEATER SET AT 2, AND IN THIS CASE THE USER HAD SET IT TO 6, WHICH IS TOO HIGH A SETTING FOR THE TYPE OF PT CONNECTION BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA - OHIO DELUXE NEBULIZER HEATER NEBULIZER HEATER CCQ OHMEDA MEDICAL 0217-6145-800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *