MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEONTAL TEMPERATURE SKIN SENSO, SKIN SENSOR 3PIN, PROBE 12; WARMER, INFANT RADIANT

Model Number	HNICU-37
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Hyperthermia (1909)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "temperature readings are coming back incorrectly, causing babies to be overheated in their radiant warmers and isolettes.".
Additional Manufacturer Narrative
A user facility reported, "temperature readings are coming back incorrectly, causing babies to be overheated in their radiant warmers and isolettes." deroyal industries requested return of the device, but it has not yet been received by the manufacturing facility.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A user facility reported, "probe is reading low, causing baby to be overheated by isolette or baby warmer." deroyal industries requested return of the device, and it was received 1/31/2025.Deroyal reviewed the returned and the thermistor chips were tested.Both chips were confirmed to be within the specifications required for testing requirements.No issues could be confirmed with the samples received.No lot number was provided, therefore the specific work order and device history record could not be reviewed.An inventory check was performed on the skin senors.50 skin sensors were reviewed and no issues were found.The failure mode and effects analysis (fmea) was reviewed and no updated was required.A review of corrective and preventive actions (capas) was completed and no related capas were found over the last two years.(b)(4).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, SKIN SENSOR 3PIN, PROBE 12
• 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21198132
• Report Number: 9613793-2025-00001
• Device Sequence Number: 7541818
• Product Code: FMT
• UDI-Device Identifier: 00749756671361
• UDI-Public: 00749756671361
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/17/2025

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: HNICU-37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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