NEONTAL TEMPERATURE SKIN SENSO, NOVAPLUS
Received Jun 25, 2026 · Event occurred Jun 16, 2026
Report 9613793-2026-00008 · MDR key 25620319
Device
Generic name
Warmer, Infant Radiant
Manufacturer
Deroyal Cientifica De Latinoamerica S.r.lModel number
VHNICU-37Product problems
- Patient Device Interaction Problem
Patient
Not reported
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
A USER FACILITY REPORTED, "OVER THE LAST 1.5 MONTHS, OUR NICU AT (B)(6) HAS SEEN AN INCREASE IN TEMPERATURE PROBE SKIN INJURIES, SOME ARE SERIOUS HARM PRESSURE INJURIES. DURING THIS TIME, NURSES ARE REPORTING THEY HAVE SEEN A CHANGE IN THE PRODUCT NOW STOCKED ON THE UNIT: DEROYAL, VHNICU-37, HYDRO-TEMP. OUT VAT TEAM IDENTIFIED THE SWITCH IN PRODUCT IN (B)(6) 2025 FOR ALL ICU AREAS. NO INJURIES/CONCERNS IDENTIFIED AT THIS TIME (TO MY KNOWLEDGE) IN THE PICU/CICU."
Additional Manufacturer Narrative
A USER FACILITY REPORTED, "OVER THE LAST 1.5 MONTHS, OUR NICU AT (B)(6) HAS SEEN AN INCREASE IN TEMPERATURE PROBE SKIN INJURIES, SOME ARE SERIOUS HARM PRESSURE INJURIES. DURING THIS TIME, NURSES ARE REPORTING THEY HAVE SEEN A CHANGE IN THE PRODUCT NOW STOCKED ON THE UNIT: DEROYAL, VHNICU-37, HYDRO-TEMP. OUT VAT TEAM IDENTIFIED THE SWITCH IN PRODUCT IN (B)(6) 2025 FOR ALL ICU AREAS. NO INJURIES/CONCERNS IDENTIFIED AT THIS TIME (TO MY KNOWLEDGE) IN THE PICU/CICU." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT HAS NOT YET BEEN RECEIVED. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.