BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA GIRAFFE OMNIBED

    MDR report key: 442350 · Received February 7, 2003

    Report

    Report Number
    1121732-2003-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2003
    Date of Event
    January 9, 2003
    Report Date
    February 7, 2003
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Removal / Correction Number
    Z-0409/0410-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2003, WHILE A PT WAS BEING TREATED ON THE SUBJECT DEVICE THE ELEVATING BASE MOVED DOWN WITHOUT BEING ACTIVATED BY THE USER. THE PT WAS CONNECTED TO AN OSCILLATOR VENTILATOR. THERE WAS SOME CONDENSATION IN THE RIGID VENTILATOR TUBING WHICH WENT DOWN THE ENDOTRACHEAL TUBE. THERE WAS A NURSE AT THE BESIDE WHO SUCTIONED THIS FLUID IMMEDIATELY, AND THE PT DID NOT SUFFER ANY NEGATIVE CONSEQUENCES. ALTHOUGH THE EQUIPMENT HAD A WARNING LABEL ON IT, INSTRUCTING THE USER TO DISABLE THE ELEVATING BASE IF THE PT WAS BEING ADMINISTERED EITHER HFOV OR ECMO (IN CONJUNCTION WITH OHMEDA MEDICAL'S MEDICAL DEVICE RECALL (Z-0409/0410-03), THE ELEVATING BASE HAD NOT BEEN DISABLED BY THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA GIRAFFE OMNIBED INFANT INCUBATOR FMT OHMEDA MEDICAL OMNIBED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention OSCILLATOR VENTILATOR