BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA

    MDR report key: 535298 · Received June 25, 2004

    Report

    Report Number
    535298
    Event Type
    Other
    Date Received
    June 25, 2004
    Date of Event
    April 19, 2004
    Report Date
    June 3, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS IN A RADIANT WARMER WITH TEMPERATURE SENSOR ON ABDOMEN. THE PT WAS PLACED ON LEFT SIDE, PUTTING SENSOR OUT OF THE DIRECT PATH OF RADIANT ENERGY. PT'S RIGHT EAR AND SHOULDER BECAME NOTICEABLY REDDENED. OPERATOR'S MANUAL WARNS THAT THE SENSOR MUST BE DIRECTLY IN THE PATH OF RADIANT ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA INFANT RADIANT WARMER FMT OHMEDA MEDICAL PANDA 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DA Other