MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEONATAL 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "the problems include: not reading accurate temperatures of the baby, probe wire twisting, or even the wire pulling out from under the cover completely and thus is no longer in contact with the baby's skin at all.The probe covers also do not stick very well to the infant's skin.We have had many more occurrences when temperatures have been outside of normal ranges, and the nurse has determined it was due to the probe not picking up the temperature correctly, as the incubator cannot accurately heat/cool down to maintain infant's temperature.We have tried trouble-shooting by adding extra layers (duoderm between probe and skin) to keep the wire from twisting, as well as tape on top of the probe cover to keep it secured to the baby's skin.We have also tried to secure the probe wire better as it pulls out from under the probe and then is no longer in contact with the baby at all.We have not found any successful solutions.The nurse has to change the temperature probe 2-3 times during their shift which uses more supplies and takes more of their time as well.Many of our babies are considered low stimulation (in order to protect the brain), so we try not to disturb them more than every 4-6 hours.However if their temperature is out range, the nurse must address the problem and keep rechecking an axillary temperature, sometimes hourly, which then disturbs the baby and puts that baby at higher risk of intraventricular hemorrhage.".
Additional Manufacturer Narrative
A user facility reported, "the problems include: not reading accurate temperatures of the baby, probe wire twisting, or even the wire pulling out from under the cover completely and thus is no longer in contact with the baby's skin at all.The probe covers also do not stick very well to the infant's skin.We have had many more occurrences when temperatures have been outside of normal ranges, and the nurse has determined it was due to the probe not picking up the temperature correctly, as the incubator cannot accurately heat/cool down to maintain infant's temperature.We have tried trouble-shooting by adding extra layers (duoderm between probe and skin) to keep the wire from twisting, as well as tape on top of the probe cover to keep it secured to the baby's skin.We have also tried to secure the probe wire better as it pulls out from under the probe and then is no longer in contact with the baby at all.We have not found any successful solutions.The nurse has to change the temperature probe 2-3 times during their shift which uses more supplies and takes more of their time as well.Many of our babies are considered low stimulation (in order to protect the brain), so we try not to disturb them more than every 4-6 hours.However, if their temperature is out range, the nurse must address the problem and keep rechecking an axillary temperature, sometimes hourly, which then disturbs the baby and puts that baby at higher risk of intraventricular hemorrhage." deroyal industries, inc.Requested return of the device, however it was unavailable for return.This investigation is ongoing and not complete at this time.No further information is available at this time.We will provide follow-up report when additional information is received.
Additional Manufacturer Narrative
A user facility reported, "the problems include: not reading accurate temperatures of the baby, probe wire twisting, or even the wire pulling out from under the cover completely and thus is no longer in contact with the baby's skin at all.The probe covers also do not stick very well to the infant's skin.We have had many more occurrences when temperatures have been outside of normal ranges, and the nurse has determined it was due to the probe not picking up the temperature correctly, as the incubator cannot accurately heat/cool down to maintain infant's temperature.We have tried trouble-shooting by adding extra layers (duoderm between probe and skin) to keep the wire from twisting, as well as tape on top of the probe cover to keep it secured to the baby's skin.We have also tried to secure the probe wire better as it pulls out from under the probe and then is no longer in contact with the baby at all.We have not found any successful solutions.The nurse has to change the temperature probe 2-3 times during their shift which uses more supplies and takes more of their time as well.Many of our babies are considered low stimulation (in order to protect the brain), so we try not to disturb them more than every 4-6 hours.However if their temperature is out range, the nurse must address the problem and keep rechecking an axillary temperature, sometimes hourly, which then disturbs the baby and puts that baby at higher risk of intraventricular hemorrhage." deroyal industries, inc.Requested return of the device, however it was unavailable for return.Deroyal was unable to review the product as it was not available.Similarly, because the lot number was not provided, the specific device history record (dhr) could not be reviewed for the product.The risk analysis was also reviewed and confirmed that no new update was required.A historical complaint review was also conducted and found that no similar failure characteristics has been reported over the past two years for this product.An inventory check was also performed on 107 eaches of the sensors and all were found to be within specifications.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 the investigation did not show any discrepancies or issues within the manufacturing process, the root cause was not able to be determined.Corrective and preventive actions: because no root cause was determined, no corrective or preventive actions have been 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 is received.

• Brand Name: NEONATAL 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: 22411052
• Report Number: 9613793-2025-00005
• Device Sequence Number: 15869246
• Product Code: FMT
• UDI-Device Identifier: 00749756671361
• UDI-Public: 00749756671361
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/04/2025

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: HNICU-37
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/04/2025
• 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
• Patient Sex: Unknown