BEUDAMED
    FDA Adverse Event Other Summary report: N

    PANDA 3500 WARMER

    MDR report key: 530943 · Received June 23, 2004

    Report

    Report Number
    1121732-2004-00004
    Event Type
    Other
    Date Received
    June 23, 2004
    Date of Event
    April 1, 2004
    Report Date
    June 23, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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. THE PT'S RIGHT EAR AND SHOULDER BECAME NOTICEABLY REDDENED. THE 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 PANDA 3500 WARMER INFANT THERMOREGULATION FMT OHMEDA MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DAY Other