MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEONATAL TEMPERATURE SKIN SENSOR; INFANT RADIANT WARMER

Model Number	HNICU-37
Medical Device Problem Codes	Output Problem (3005); Temperature Problem (3022)
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order involved was traced and it was confirmed that the functional results were reviewed.It was confirmed that all results were found within the specification.We are still waiting for product to be returned to perform functional inspection.The investigation is incomplete at this time, a follow-up will be submitted with additional information once received, this report will be updated.
Event or Problem Description
Several babies got cold while using probe, another probe was used; however, it did not register temperature at all.
Additional Manufacturer Narrative
The defective samples were received at the manufacturing facility, a functional test (involvement of thermal bath to obtain results in ohms) was conducted to all units and the results obtained were found within the tolerance, no root cause is determined.Product in process were submitted for a functional test and it was confirmed that all results were found within specification.An inventory check related to product hnicu-37 had seven cases of work orders, three of which were related to the lot involving the complaint.A visual and functional inspection was conducted.After completion of the tests it was confirmed that all the units were found within the tolerance.In addition, a visual inspection was performed to 100% of the units and no discrepancies were identified.Complaint's log of the last two years confirmed a total of 18 complaints generated with the same or similar part number, two of those cases have been related to a shipping issue, in two cases it has been determined "use error" as a root cause, for the rest of the cases, the root cause has been identified as "undetermined"; therefore, it has been confirmed that no issues related to the functionality of the medical device have been demonstrated.Due to increase in number of complaints related to the functionality, a corrective action an internal corrective action point has been opened to fully research reported issues with the product.The 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.

• Brand Name: NEONATAL TEMPERATURE SKIN SENSOR
• Common Device Name: INFANT RADIANT WARMER
• 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
• MDR Report Key: 11855875
• Report Number: 9613793-2021-00013
• Device Sequence Number: 4016737
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1