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	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Baby got hot.
Additional Manufacturer Narrative
A user facility reported that "baby got hot" when using the hnicu-37 probe.A sample has been requested but has not yet been returned to deroyal.This report came in as one complaint, but because it described seven separate events, it will be reported for each event.This report is three of seven (3/7).This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is available.
Additional Manufacturer Narrative
A user facility reported that "baby got hot" when using the hnicu-37 probe.For the seven complaints filed, seven lots were listed.Samples were requested for these complaints, however only samples from one lot were returned.The sample from this lot 58195314 was returned and able to be evaluated.This report came in as one complaint, but because it described seven separate events, it will be reported for each event.This report is three of seven (3/7).The two samples were returned and functional testing was conducted.One chip within the sample wsa measured to be above the maximum limit.Function results of the work orders pulled were reviewed and it was confirmed that no discrepancies were reported during the manufacturing process.Deroyal completed an inventory check on 125 probes and all were found to be acceptable.A review of work orders of 80 cases were also reviewed and no issues were found.The device history record was also reviewed and no issues were identified.Root cause: after functional inspection of the returned samples, it can be concluded tht there was a failure by the grinding manufacturing operator, since the wire set was grinded above to the maximum limit, in addition, it was not detected during the 100% inspection performed after grinding operation.As a root cause it is determined that grinding procedure and testing procedure were not followed correctly by the operator.Corrective and preventive action: deroyal conducted a retraining in both the grinding and testing procedures for the applicable personnel.A complaint to sales ratio was conducted over the past two years.From that time period, a complaint ratio of (b)(4) was found.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 more 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: 19940389
• Report Number: 9613793-2023-00009
• Device Sequence Number: 4877489
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: HNICU-37
• Device Lot Number: 57174052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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