Resuscitaire Birthing Room Warmer (WBR82) MU20512Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098000185), received between May 25, 2022 and May 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (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.
Most reported problems
Device problems
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2022Smoking; Smoking
IT WAS REPORTED THAT THE CONTROLLER OF THE UNIT HAD BURNED DURING THE PRE-USE WARMUP. THE BIOMED FURTHER CLARIFIED THAT SMOKE WAS BILLOWING OUT OF THE UNIT, BUT NO EVACUATION WAS REQUIRED. THERE WAS NO REPORT OF VISIBLE FLAMES, BUT THE SOOT TRAILS INDICATE A FIRE. THERE WAS NO INJURY REPORTED IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14501441 ↗
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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