MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEO. TEMP PROBE 12 PINK, FOR USE WITH NI CABLE; WARMER, INFANT RADIANT

Model Number	FNICU-37
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Hyperthermia (1909)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "baby temperature is reading hypothermic and it is getting the babies too hot" a sample was requested to be returned to deroyal industries but was not able to be returned.Deroyal reviewed failure modes and effects analysis (fmea) and corrective action and preventive action and found no issues.An inventory check was performed on 125 probes and no issues were found.(b)(4).Root cause: because no sample was returned and it was not possible to perform an inspection of the lot involved, a root cause could not be determined.Corrective and preventive actions: no actions were taken as the root cause could not be identified.Deroyal will continue to monitor for trends surrounding 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.
Event or Problem Description
A user facility reported, "baby temperature is reading hypothermic and it is getting the babies too hot.".

• Brand Name: NEO. TEMP PROBE 12 PINK, FOR USE WITH NI CABLE
• 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
• MDR Report Key: 19950682
• Report Number: 9613793-2023-00016
• Device Sequence Number: 8810803
• Product Code: FMT
• UDI-Device Identifier: 00749756885447
• UDI-Public: 00749756885447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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
• Device Model Number: FNICU-37
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown