MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEONTAL TEMPERATURE SKIN SENSO, NOVAPLUS; WARMER, INFANT RADIANT

Model Number	VHNICU-37
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "the temperature is not reading properly and is not working well with ge giraffe beds.".
Additional Manufacturer Narrative
A user facility reported, "the temperature is not reading properly and is not working well with ge giraffe beds." deroyal industries, inc.Requested return of the device, however, it was listed as not available for return.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.
Additional Manufacturer Narrative
A user facility reported, "the temperature is not reading properly and is not working well with ge giraffe beds." deroyal industries, inc.Requested return of the device, however, it was listed as not available for return.Deroyal could not review the specific device history record (dhr) as the lot number of the device was not provided.An inventory check was conducted on 125 eaches and all were found to be within specification.125 samples that were in-work were also subjected to functional testing.No defects or abnormalities were found.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: because the sample nor lot number were provided and no issues were identified within the manufacturing review, the specific root cause could not be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: NEONTAL TEMPERATURE SKIN SENSO, NOVAPLUS
• 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: 23815385
• Report Number: 9613793-2025-00010
• Device Sequence Number: 18666600
• Product Code: FMT
• UDI-Device Identifier: 00749756927574
• UDI-Public: 00749756927574
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: VHNICU-37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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