inforMED
MalfunctionFMT

DEROYAL

Received Jul 22, 2026 · Event occurred Jun 29, 2026

Report 25904502 · MDR key 25904502

Device

Generic name

Warmer, Infant Radiant

Model number

VHNICU-37

Catalog number

VHNICU-37

Lot number

63233792

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

TEMPERATURE PROBE STICKER WAS HOOKED UP TO THE RADIANT WARMER. TEMPERATURE PROBE STICKER HAD JUST BEEN CHANGED OUT AT MOST RECENT CARE TIME. PROBE STICKER WAS IN AN APPROVED LOCATION FOR PLACEMENT. BED WAS IN BABY MODE, TO BE REGULATED BY TEMPERATURE PROBE. TEMPERATURE WAS NOTED TO BE READING 38.2 DEGREES. INFANT'S TEMPERATURE WAS IMMEDIATELY CHECKED AXILLARY AND NOTED TO BE 37.4. INFANT'S TEMPERATURE WAS BETTER AFTER REMOVING PROBE AND ADJUSTING INFANT/ BED. PER LEADER REVIEW OF EVENT: "AFTER MARKET TEMPERATURE PROBES HAVE BEEN PROBLEMATIC. APPLICATION OF TEMPERATURE PROBE WAS APPROPRIATE AND THERE WAS NO BED ISSUE NOTED. INFANT HAD NO HARM AND REMAINED WITHIN A NORMOTHERMIC RANGE OF 37.4 DEG C."