DeRoyal HNICU-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756255608), received between Jan 9, 2020 and Jan 30, 2026 — 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Device Dislodged or Dislocated

  A USER FACILITY REPORTED, "THE PROBE COVERS NOT PROPERLY MOLDING AND ADHERING TO THE PATIENT'S SKIN TO HOLD DOWN THE NICU PROBE TO THE PATIENT'S SKIN. SEVERAL PATIENTS HAVE OVERHEATED DUE TO THE PROBE NOT PROPERLY MOLDING AND ADHERING TO THE PATIENT'S SKIN."

  Patient problems: Hyperthermia

  MAUDE report 24222173 ↗
• MalfunctionOct 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE PROBE COVER IS NOT STICKING TO THE PATIENT AROUND THE PROBE, CAUSING IT TO LIFT UNDER THE COVER. THERE WAS AN ELEVATED TEMPERATURE OF 99.8°F TO 100.3°F, HOWEVER THE GIRAFFE WAS READING COOLER TEMPERATURES OF 97.8°F-98.0°F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582531 ↗
• MalfunctionOct 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE PROBE COVER IS NOT STICKING TO THE PATIENT AROUND THE PROBE, CAUSING IT TO LIFT UNDER THE COVER. THERE WAS AN ELEVATED TEMPERATURE OF 99.8°F TO 100.3°F, HOWEVER THE GIRAFFE WAS READING COOLER TEMPERATURES OF 97.8°F-98.0°F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582530 ↗
• MalfunctionOct 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE PROBE COVER IS NOT STICKING TO THE PATIENT AROUND THE PROBE, CAUSING IT TO LIFT UNDER THE COVER. THERE WAS AN ELEVATED TEMPERATURE OF 99.8°F TO 100.3°F, HOWEVER THE GIRAFFE WAS READING COOLER TEMPERATURES OF 97.8°F-98.0°F.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582529 ↗
• MalfunctionJan 9, 2020Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  WHEN THE TEMP SENSOR IS USED ON THE MICRO-PREEMIE POPULATION, THE PAD IS SLIDING. THE GEL ON THE BACK LOSES ITS "STICKY" PROPERTY, WHICH CAUSES THE DEVICE TO NOT STICK TO THE SKIN. THE NURSES ARE REPORTING UNSTABLE TEMPERATURES IN THAT POPULATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9570128 ↗