BEUDAMED
    FDA Adverse Event Other Summary report: N

    C100 INFANT INCUBATOR

    MDR report key: 432994 · Received December 11, 2002

    Report

    Report Number
    2510954-2002-00011
    Event Type
    Other
    Date Received
    December 11, 2002
    Date of Event
    April 1, 2002
    Report Date
    December 6, 2002
    Manufacturer
    HILL-ROM AIRSHIELDS
    Product Code
    FPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS INCUBATOR HAD BEEN TURNED OFF THOUGH THE PT. STILL THERE. HEATING ELEMENT TURNED OFF, PATIENT TEMPERATURE FELL TO 33.5 DEGREES C BEFORE NOTICED. PATIENT REWARMED, NO INJURY. DATE OF INCIDENT: 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C100 INFANT INCUBATOR INFANT INCUBATOR FPL HILL-ROM AIRSHIELDS C100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other