DeRoyal HNICU-00Recalls & reported problems
Deroyal Industries, Inc. · HYDRO-TEMP® Cover with Foam · Class 2
Data updated Oct 13, 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 00749756032421), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Mechanical Problem1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2019Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement
THE TEMPERATURE PROBE COVER IS PEELING OFF THE PATIENT'S SKIN, CAUSING MISREADING. IT WAS PLACED ON THE NEONATE'S STOMACH. NO INJURY WAS REPORTED, BUT STAFF INTERVENTION WAS NECESSARY. THE MISREADING REQUIRED THE STAFF TO ADJUST THE ISOLETTE TEMPERATURE, WHICH CHANGED DUE TO THE FALSE TEMPERATURE READING. THE READING FALSELY INDICATED THE INFANT'S TEMPERATURE WAS DECREASING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9122615 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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