MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HYDRO-TEMP 3 NEONATAL PROBE, ORANGE; WARMER, INFANT RADIANT

Model Number	HNICU-26
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "we had our biomed check out the probes compared to the ohmeda probes we are currently using and we found two alarming issues with it.The first is that the deroyal probe had a very large lag time, minutes, before it senses the new temperature.The second issue is that when it did change temperatures it was about 3 celcious off from the ohmeda probe." deroyal industries, inc.Requested return of the device but it has yet to be 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.
Event or Problem Description
A user facility reported, "we had our biomed check out the probes compared to the ohmeda probes we are currently using and we found two alarming issues with it.The first is that the deroyal probe had a very large lag time, minutes, before it senses the new temperature.The second issue is that when it did change temperatures, it was about 3 celcious off from the ohmeda probe.".

• Brand Name: HYDRO-TEMP 3 NEONATAL PROBE, ORANGE
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23815386
• Report Number: 9613793-2025-00011
• Device Sequence Number: 10098708
• Product Code: FMT
• UDI-Device Identifier: 00749756032384
• UDI-Public: 00749756032384
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HNICU-26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown