DeRoyal HNICU-37Recalls & reported problems
Deroyal Industries, Inc. · HYDRO-TEMP® Neonatal Temperature Skin Sensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This DeRoyal neonatal skin temperature sensor sticks to a baby's skin to help control warmers and incubators. Reports mostly describe inaccurate or low temperature readings, with probes twisting, coming loose or not sticking, and mention babies becoming overheated. There are 25 reports naming its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00749756671361), received between Feb 18, 2021 and Jul 7, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (12 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem12
- Output Problem12
- Incorrect, Inadequate or Imprecise Result or Readings11
- Unable to Obtain Readings3
- Temperature Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Alteration in Body Temperature10
- Hyperthermia3
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "THE PROBLEMS INCLUDE: NOT READING ACCURATE TEMPERATURES OF THE BABY, PROBE WIRE TWISTING, OR EVEN THE WIRE PULLING OUT FROM UNDER THE COVER COMPLETELY AND THUS IS NO LONGER IN CONTACT WITH THE BABY'S SKIN AT ALL. THE PROBE COVERS ALSO DO NOT STICK VERY WELL TO THE INFANT'S SKIN. WE HAVE HAD MANY MORE OCCURRENCES WHEN TEMPERATURES HAVE BEEN OUTSIDE OF NORMAL RANGES, AND THE NURSE HAS DETERMINED IT WAS DUE TO THE PROBE NOT PICKING UP THE TEMPERATURE CORRECTLY, AS THE INCUBATOR CANNOT ACCURATELY HEAT/COOL DOWN TO MAINTAIN INFANT'S TEMPERATURE. WE HAVE TRIED TROUBLE-SHOOTING BY ADDING EXTRA LAYERS (DUODERM BETWEEN PROBE AND SKIN) TO KEEP THE WIRE FROM TWISTING, AS WELL AS TAPE ON TOP OF THE PROBE COVER TO KEEP IT SECURED TO THE BABY'S SKIN. WE HAVE ALSO TRIED TO SECURE THE PROBE WIRE BETTER AS IT PULLS OUT FROM UNDER THE PROBE AND THEN IS NO LONGER IN CONTACT WITH THE BABY AT ALL. WE HAVE NOT FOUND ANY SUCCESSFUL SOLUTIONS. THE NURSE HAS TO CHANGE THE TEMPERATURE PROBE 2-3 TIMES DURING THEIR SHIFT WHICH USES MORE SUPPLIES AND TAKES MORE OF THEIR TIME AS WELL. MANY OF OUR BABIES ARE CONSIDERED LOW STIMULATION (IN ORDER TO PROTECT THE BRAIN), SO WE TRY NOT TO D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411052 ↗MalfunctionMay 20, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "WE HAD AN INFANT IN A NEW GIRAFFE THIS MORNING WHO WAS HAVING SOME THERMOREGULATION ISSUES RELATED TO THE PROBE."
Patient problems: Alteration in Body Temperature
MAUDE report 22054049 ↗MalfunctionFeb 6, 2025Device Sensing Problem; Device Sensing Problem
AN END CONSUMER REPORTED, "TEMPERATURE PROBE IS READING TOO LOW CAUSING THE BABY TO BE OVERHEATED BY THE ISOLETTE OR WARMER. THIS IS CAUSING THE PATIENT TO BE TESTED AND NEED ADDITIONAL CARE TO RETURN TO NORMOTHERMIA."
Patient problems: Hyperthermia
MAUDE report 21327161 ↗MalfunctionFeb 6, 2025Device Sensing Problem; Device Sensing Problem
AN END CONSUMER REPORTED, "PROBE IS READING LOW, CAUSING BABY TO BE OVERHEATED BY ISOLETTE OR BABY WARMER. "
Patient problems: Hyperthermia
MAUDE report 21327160 ↗MalfunctionJan 21, 2025Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, "TEMPERATURE READINGS ARE COMING BACK INCORRECTLY, CAUSING BABIES TO BE OVERHEATED IN THEIR RADIANT WARMERS AND ISOLETTES."
Patient problems: Hyperthermia
MAUDE report 21198132 ↗MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 8, 2024Device Sensing Problem; Device Sensing Problem
MalfunctionAug 20, 2021Output Problem; Temperature Problem; Output Problem; Temperature Problem
HNICU-37 DID NOT PROVIDE ACCURATE TEMPERATURE AND DID NOT AFFECT THE PATIENT, THE PROBE WAS SWITCHED OUT.
Patient problems: Alteration in Body Temperature
MAUDE report 12347542 ↗MalfunctionMay 20, 2021Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
TEMPERATURE READINGS WERE NOT ACCURATE ON THE NEW STYLE HNICU PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11855880 ↗MalfunctionMay 20, 2021Output Problem; Temperature Problem; Output Problem; Temperature Problem
SEVERAL BABIES GOT COLD WHILE USING PROBE, ANOTHER PROBE WAS USED; HOWEVER, IT DID NOT REGISTER TEMPERATURE AT ALL.
Patient problems: Alteration in Body Temperature
MAUDE report 11855875 ↗MalfunctionMar 18, 2021Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
NURSING STAFF IS HAVING AN ISSUE WITH THE BLUE TIP PART (PRODUCT REF # HNICU - 37) NOT TAKING AN ACCURATE TEMPERATURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11518800 ↗MalfunctionMar 18, 2021Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
DURING SKIN ROUNDS IN OUR NICU THE PROBE WAS BROUGHT TO ATTENTION WITH CONCERNS ON THE FEEL AND FUNCTIONALITY. BOTH THE NURSE AND WOUND CARE NURSE NOTICED THAT THIS WAS A DIFFERENT TEMP PROBE THAT HAS BEEN USED WITH THE GIRAFFE ISOLETTE. THE 'WIRE' WAS KINKY AND DID NOT LAY AS FLAT AS IN THE PREVIOUS PRODUCT. WE ALSO NOTED THAT THE BLUE TIP COVERING THE SENSORS DID NOT SEEM TO BE AS 'THICK' AS COMPARED TO THE PREVIOUS ONE WITH A 'WHITE' END. THIS COULD HAVE BEEN BECAUSE WE REALLY COULD NOT SEE THE SENSORS THROUGH THE 'WHITE' TIP, BUT THE PRODUCT FELT AS IF YOU COULD FEEL THOSE SENSORS EASILY. THE NURSE HAD STATED THAT SHE HAD WENT TO RETRIEVE ANOTHER ONE BECAUSE SHE WAS NOT SURE IF THE SENSOR WAS ACCURATELY GETTING A GOOD TEMP AND HAD TO APPLY TWO SENSOR PROBE COVERS OVER THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11518761 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342132 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342131 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342130 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342129 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342128 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342126 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342124 ↗MalfunctionFeb 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
A WARMER ALARMED, NOTIFYING THE BABY'S TEMPERATURE REGISTERED AS LOW. HOWEVER, THE TEMPERATURE WAS NORMAL OR HIGH, AND THE WARMER CONTINUED TO INCREASE TEMPERATURE. THE WARMER WAS CHECKED BY BIOMED AND SERVICED BY GE. IT WAS CONFIRMED THE WARMER WAS FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11342122 ↗
Other WARMER, INFANT RADIANT devices
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- Panda i-Res Warmer 1.0Datex-Ohmeda, Inc. · WARMER, INFANT RADIANT1 recall15 reports
- Panda iRes WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT34 reports
- Giraffe WarmerDatex-Ohmeda, Inc. · WARMER, INFANT RADIANT27 reports
- F&P Neopuff RD900AFUFisher & Paykel Healthcare Limited · Warmer, Infant Radiant18 reports
- DeRoyal HNICU-03Deroyal Industries, Inc. · WARMER, INFANT RADIANT5 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 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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