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	Alteration in Body Temperature (4568)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "we had an infant in a new giraffe this morning who was having some thermoregulation issues related to the probe." deroyal industries, inc.Requested the return of the device, but it was unavailable for return.The investigation is ongoing and 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 an infant in a new giraffe this morning who was having some thermoregulation issues related to the probe.".
Additional Manufacturer Narrative
A user facility reported, "we had an infant in a new giraffe this morning who was having some thermoregulation issues related to the probe." deroyal industries, inc.Requested the return of the device, but it was unavailable for return.Because no lot number was provided with the complaint, the specific device history record could not be reviewed.An inventory check was also performed on 80 neonatal skin sensors and all were found to be within specification.The risk analysis and corrective and preventive actions were reviewed for the device.No issues were found and no updates were required.A complaint to sales ratio was conducted over the last two years and found to be (b)(4).Root cause: because the device nor lot number were provided and no issues were found in the investigation, no root cause was able to be determined.Corrective and preventive actions: because no root cause was able 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 a 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 facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22054049
• Report Number: 9613793-2025-00004
• Device Sequence Number: 20131873
• Product Code: FMT
• UDI-Device Identifier: 00749756671361
• UDI-Public: 00749756671361
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/03/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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