BEUDAMED
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    RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESUSCITAIRE

    FDA Adverse Event
    Other ·DRAEGER MEDICAL SYSTEMS, (PNC)·Product code FMT·October 25, 2007

    RW RESUSCITAIRE

    FDA Adverse Event
    Other ·HILL-ROM MANUFACTURING INC·Product code FMT·June 4, 2001

    FREE STANDING INFANT WARMER

    FDA Adverse Event
    Malfunction ·AIR-SHIELDS·Product code FMT·October 23, 1996

    BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION

    FDA Adverse Event
    Injury ·BAXTER·Product code FPA·March 14, 2011

    GIRAFFE OMNIBED WITH EXAM LIGHT

    FDA Adverse Event
    Malfunction ·GE MEDICAL·Product code FMZ·January 25, 2012

    TAMPAX RADIANT TAMPON, SUPER UNSCENTED

    FDA Adverse Event
    Injury ·TAMBRANDS MANUFACTURING, INC·Product code HEB·September 5, 2013

    RESUSCITAIRE RADIANT WARMER

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL INFANT CARE, INC.·Product code FMT·November 14, 2022

    HARMONYAIR

    FDA Adverse Event
    Malfunction ·STERIS CORPORATION·Product code FSY·March 20, 2025

    AIRLIFE

    FDA Adverse Event
    Malfunction ·SALTER LABS·Product code NFB·January 2, 2026

    TEMPERATURE PROBE

    FDA Adverse Event
    Malfunction ·ELECTROMEDICS, INC.·Product code FLL·March 8, 1994

    STETHOSCOPE (NURSES)

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code LDE·January 5, 1993

    CAREFUSION

    FDA Adverse Event
    Injury ·CAREFUSION·Product code CBK·July 3, 2012

    AIR SHIELDS RADIANT INFANT WARMER

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FMT·March 22, 1994

    UNKNOWN

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FMT·January 28, 1992

    Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.

    FDA Recall
    Terminated ·Ohmeda Medical, A Div of Datex-Ohmeda Inc·Product code FMZ·October 17, 2003

    NEOBLUE 3 LED PHOTOTHERAPY SYSTEM

    FDA Adverse Event
    Malfunction ·NATUS MEDICAL INCORPORATED·Product code LBI·August 17, 2017

    INFANT INTENSIVE CARE SYSTEM

    FDA Adverse Event
    Death ·AIR-SHEILDS·Product code FMT·April 2, 1992

    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.

    FDA Enforcement
    Class II ·Terminated·Atom Medical Corporation·July 18, 2012

    IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician s training and experience and then is adjusted based on the patients needs and clinical status. 2. Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems

    FDA Recall
    Terminated ·Ohmeda Medical·Product code FMT·November 18, 2016