BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR SHIELDS ISOLETTE INFANT INCUBATOR

    MDR report key: 258826 · Received January 11, 2000

    Report

    Report Number
    2510954-2000-00001
    Event Type
    Other
    Date Received
    January 11, 2000
    Date of Event
    October 6, 1999
    Report Date
    November 5, 1999
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE ASSESSMENT, A NURSE REMOVED A TEMPERATURE PROBE COVER AND TEMPERATURE PROBE FROM THE PT'S ABDOMEN. SHE DISCOVERED A 3RD DEGREE BURN 1.5 CM IN DIAMETER WHERE THE PROBE WAS IN CONTACT WITH THE SKIN. ACCORDING TO THE CHARTING AT THE TIME OF THE INCIDENT, THE AIR TEMPERATURE INSIDE THE INCUBATOR WAS 92 DEGREES FAHRENHEIT AND THE PT'S SKIN TEMPERATURE WAS DISPLAYED AT 98.1 DEGREES FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS ISOLETTE INFANT INCUBATOR INFANT INCUBATOR FMT HILL-ROM AIR-SHIELDS C2HS-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other