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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Five samples were returned to deroyal on may 5, 2023.These were representative samples from the user facility, not the actual device described in the complaint.Two of the returned devices were from the work order under investigation.Functional tests were conducted on all returned samples with each being within tolerance and no issues found.Device history records and work orders were reviewed with no issues found.An inventory check was made on 125 skin sensors and no issues were identified.A complaint to sales ratio was conducted over the past two years.A total of 110,100 skin sensors were sold with only one complaint in that same time frame.This represents a ratio of 0.000009, or 0.0009%.Root cause: because functional results were all found within the tolerance and no discrepancies were identified in the documentation, a root cause cannot be determined.Corrective and preventative actions: because the issue could not be identified and no root cause could be established, no corrective or preventative actions were taken.Deroyal will continue to monitor for trends around this issue and item.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.
Additional Manufacturer Narrative
A user facility reported on 4/19/2023, that "the temperature probes are overheating.The isolettes are overheating when using the temperature probes.This is happening on older and new model isotlettes.They have even switched out an isolette 3 times with a patient to see if it was a bed issue." no injury occurred, but it was reported that medical attention was required to prevent impairment.The sample has been requested, but has not yet been returned to deroyal industries.This 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
The temperature probes are overheating.The isolettes are overheating when using the temperature probes.This is happening on older and new model isotlettes.They have even switched out an isolette 3 times with a patient to see if it was a bed issue.

• 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19931701
• Report Number: 9613793-2023-00006
• Device Sequence Number: 2736655
• Product Code: FMT
• UDI-Device Identifier: 00749756927574
• UDI-Public: 00749756927574
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/05/2023

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
• Device Model Number: VHNICU-37
• Device Lot Number: 57918445
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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
• Patient Sex: Unknown