DeRoyal HNICU-38Recalls & reported problems
Deroyal Industries, Inc. · HYDRO-TEMP® Neonatal Temperature Skin Sensor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756666688), received between Aug 7, 2024 and Aug 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Failure to Sense2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Failure to Sense; Device Dislodged or Dislocated; Failure to Sense; Device Dislodged or Dislocated
CONNECTOR ON THE END OF PROBE WAS FALLING OUT OF THE MACHINE EITHER DURING INITIAL USE OR AFTER A FEW HOURS. BABIES TEMPERATURES WERE NOT MONITORED ALLOWING OPPORTUNITY FOR SEVERE DANGER OF OVERHEATING TO BABIES. PLUG WOULD ALSO REGISTER ERROR SIGN SOMETIMES WHEN PLUGGED INTO MACHINE. DO NOT HAVE SAMPLES OF ACTUAL DEFECTIVE PRODUCTS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931706 ↗MalfunctionAug 7, 2024Failure to Sense; Device Dislodged or Dislocated; Failure to Sense; Device Dislodged or Dislocated
CONNECTOR ON THE END OF PROBE WAS FALLING OUT OF THE MACHINE EITHER DURING INITIAL USE OR AFTER A FEW HOURS. BABIES TEMPERATURES WERE NOT MONITORED ALLOWING OPPORTUNITY FOR SEVERE DANGER OF OVERHEATING TO BABIES. PLUG WOULD ALSO REGISTER ERROR SIGN SOMETIMES WHEN PLUGGED INTO MACHINE. DO NOT HAVE SAMPLES OF ACTUAL DEFECTIVE PRODUCTS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931705 ↗
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 81-010400Deroyal 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page