Babyroo TN300 Infant Radiant Warmer MU20300Recalls & reported problems
Draeger Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098099042), received between May 30, 2024 and May 30, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Excessive Heating” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Excessive Heating1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2024Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating
THE CUSTOMER REPORTED THAT THE BABYROO WAS SET TO 36.9 CELSIUS WITH NO HUMIDIFIER, TO WARM THE BABY THAT HAD A SKIN TEMPERATURE OF 36.2°C. THE CUSTOMER REPORTED THAT BABY'S SKIN ON THE REAR OF THE THE THIGH WAS BURNT (RED SKIN), AND THAT THE DEVICE DID NOT TRIGGER ANY ALARM, AND THAT THE RADIAN WAS WARM. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THAT THE DEGREE WAS FIRST DEGREE, AND THAT THERE WAS A SLIGHT REDNESS PRESENT ON THE CALF THAT WENT AWAY WITHIN 30 MINUTES OF A COLD COMPRESS. THERE WAS NO OTHER FOLLOW UP AND NO BLISTERING. THE ADDITIONAL INFORMATION PROVIDED STATED THAT THE BABY WAS WITHIN HOURS OF BEING BORN, AND WEIGHED 2.340 KG. THE BABY WAS MOVED AWAY FROM THE RADIAN IN A LOCATION THAT KEPT THE BABY WARM BUT NOT DIRECTLY HEATED, AND A PEDIATRICIAN WAS CALLED IN. THE PATIENT WAS CONFIRMED TO BE IN GOOD CONDITION WITH NO REMAINING CONSEQUENCES. THE CUSTOMER CONFIRMED THAT THE PRE-USE CHECKOUT WAS PERFORMED, AND THAT THEY DID NOT USE A HEATED WARMER. A CENTRAL SKIN TEMPERATURE PROBE WAS POSITIONED ON THE ABDOMEN AND SECURED WITH A SUITABLE DEVICE. THE BABY HAD NO CLOTHING, JUST A NAPPY WITH A CAP OVER HIS HEAD.
Patient problems: Superficial (First Degree) Burn
MAUDE report 19430376 ↗
Other Warmer, Infant Radiant devices
- F&P Neopuff RD900AEUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant433 reports
- Panda i-Res Warmer 1.0Datex-Ohmeda, Inc. · WARMER, INFANT RADIANT1 recall15 reports
- Resuscitaire Radiant Warmer (RW82, RW82 VHA) MU20503Draeger Medical Systems, Inc. · Warmer, Infant Radiant1 recall3 deaths15 reports
- Panda iRes WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT34 reports
- Giraffe WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT27 reports
- DeRoyal HNICU-37Deroyal Industries, Inc. · WARMER, INFANT RADIANT25 reports
- F&P Neopuff RD900AFUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant18 reports
- DeRoyal HNICU-03Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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