DeRoyal HNICU-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756166317), received between Oct 28, 2025 and Oct 28, 2025 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A USER FACILITY REPORTED THROUGH A MEDWATCH, "RN WENT INTO ROOM TO RESPOND TO THE BED ALARMING "PATIENT HOT". RN TOOK INFANTS TEMPERATURE, AND IT READ 38.6. RN AIRED INFANT OUT AND RETOOK TEMP 30 MIN LATER. TEMP 38. RN ENCOURAGED MOM TO DO SKIN TO SKIN WITH INFANT TO HELP REGULATE A NORMAL TEMPERATURE AGAIN. MOM DID SKIN TO SKIN AND INFANT RETURNED TO A NORMAL TEMPERATURE. STICKER REPLACED AT EVERY CARE DUE TO IT NOT HOLDING THE TEMP PROBE ON THE INFANT THROUGHOUT ENTIRE SHIFT. STICKER NOT STAYING ON BABIES AND NOT HELPING THE BED REGULATE APPROPRIATE TEMPERATURE OUTPUTS."

  Patient problems: Hyperthermia

  MAUDE report 23401723 ↗