DeRoyal 81-010400Recalls & reported problems
Deroyal Industries, Inc. · Skin Temperature Sensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756046169), received between Oct 26, 2018 and Oct 29, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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
- Incorrect, Inadequate or Imprecise Result or Readings3
- Low Readings3
- Output Problem3
- Device Sensing Problem1
- Incorrect Interpretation of Signal1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
A USER FACILITY REPORTED, "THE TEMPERATURE IS JUMPING FROM ONE TEMP TO THE NEXT. EX- 36 TO 25 TO 38 TO 8."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416850 ↗MalfunctionAug 12, 2024Device Sensing Problem; Device Sensing Problem
A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960641 ↗MalfunctionOct 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem
THE TEMPERATURE PROBE WAS READING LOW DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8008644 ↗MalfunctionOct 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem
THE TEMPERATURE PROBE WAS READING LOW DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8008643 ↗MalfunctionOct 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem
THE TEMPERATURE PROBE WAS READING LOW DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8008642 ↗
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- 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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