BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA INFANT WARMER SYSTEMS

    MDR report key: 268435 · Received March 13, 2000

    Report

    Report Number
    1121732-2000-00002
    Event Type
    Injury
    Date Received
    March 13, 2000
    Date of Event
    February 15, 2000
    Report Date
    February 16, 2000
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE INFANT WAS BEING TREATED IN THE SUBJECT DEVICE, PT BECAME AGITATED AND PT'S BACK BECAME REDDENED AND HOT TO TOUCH. THE UNIT WAS BEING USED IN PT CONTROL MODE, WITH A CONTROL TEMPERATURE OF 36.4C. THE PT'S TEMPERATURE DISPLAYED AT 35.1C, AND THE BABY'S RECTAL TEMPERATURE MEASURED 38.9C. AN OHMEDA DISPOSABLE PROBE HAD BEEN IN USE, AND A NURSE REPLACED IT WITH A REUSABLE PROBE. THE PT'S TEMPERATURE RETURNED TO WITHIN SPECS. HOSP'S BIOMEDICAL ENGINEER THOROUGHLY EVALUATED THE WARMER AND FOUND THAT IT FUNCTIONED PROPERLY AND WAS WELL WITHIN SPECS. THE PROBE WAS THOROUGHLY TESTED AT OHMEDA MEDICAL AND IT, TOO, WAS FOUND TO FUNCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA INFANT WARMER SYSTEMS INFANT RADIANT WARMER FMT OHMEDA MEDICAL IWS 4300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention