MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L NEONATAL TEMPERATURE SKIN SENSOR; INFANT 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	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective product has been discarded, 25 samples from the same lot (#54386480) are being returned for evaluation.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
Hnicu-37 did not provide accurate temperature and did not affect the patient, the probe was switched out.
Additional Manufacturer Narrative
Twenty six samples of same product, but another lot (#53968728) were returned at the manufacturing facility.All samples were functionally tested and was confirmed to be within specifications as per respective drawing.Therefore, it was concluded that no issues were identified in none of the samples returned by the customer.Complaint log review for the last two years confirmed a total of 21 complaints for the family product of fnicu-25, hnicu-26, vnicu-37, hnicu-37.Two of those cases have been related to a shipping issue, other two cases determined to be "use error".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, 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 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: 12347542
• Report Number: 9613793-2021-00016
• Device Sequence Number: 19818180
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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
• Device Lot Number: 54386480
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1