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	Hyperthermia (1909)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the probes were reading the wrong temperatures and overheating the babies." deroyal industries, inc.Has requested return of the device but it was stated that it was not available for return.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Event or Problem Description
A user facility reported, "the probes were reading the wrong temperatures and overheating the babies.".
Additional Manufacturer Narrative
A user facility reported, "the probes were reading the wrong temperatures and overheating the babies." deroyal industries, inc.Has requested return of the device but it was stated that it was not available for return.Because the lot number was not reported, the specific device history record was not able to be reviewed.An inventory check was performed on a case at the distribution center.No issues were found.Procedures around the neonatal probe were reviewed and it was confirmed that there were clear instructions were detecting defective product.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: because the sample nor the lot number were provided and no issues were found within the manufacturing record review, the root cause was unable to 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.The 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: 24085005
• Report Number: 9613793-2026-00002
• Device Sequence Number: 9776230
• Product Code: FMT
• UDI-Device Identifier: 00749756927574
• UDI-Public: 00749756927574
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VHNICU-37
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/03/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown