MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU - 37 - NEONATAL TEMPERATURE SKIN SENSO, SKIN SENSOR 3PIN, PROBE 12; NEONATAL TEMPERATURE SKIN SENSOR

Model Number	HNICU-37
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause was undetermined.Corrective action: a correction action was not taken.Investigation: due to product not returned no inspection was performed.No review of device history record was performed due to lot number was not provided.Failure mode effective analysis (acd.Fmea.064 neonatal temperature prode, rev e) was reviewed and confrimed that there are several failure modes identified related to the issue under investigation, in regards to incorrect temperature reading.Complaint's log of the last two years confirmed following compliants of the same family generated due to functionality issue and root cause was undetermined.Product process sub-assembly (b)(4) was inspected, work order (b)(4), total of 80 samples tested and resulted all pass qc functional test.During the period of july 2020 - march 2021, deroyal sold (b)(4) hnicu products, with (b)(4) reported complaints.This is a low total frequency of complaints relative to selling units.The investigation is complete at this time.If new and critical information is recevied, this report will be updated.
Event or Problem Description
Nursing staff is having an issue with the blue tip part (product ref # hnicu - 37) not taking an accurate temperature.

• Brand Name: HNICU - 37 - NEONATAL TEMPERATURE SKIN SENSO, SKIN SENSOR 3PIN, PROBE 12
• Common Device Name: NEONATAL TEMPERATURE SKIN SENSOR
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park; box 180-3006, 602 parkway; la aurora, heredia, ; CS
• MDR Report Key: 11518800
• Report Number: 9613793-2021-00009
• Device Sequence Number: 19652333
• Product Code: FMT
• UDI-Device Identifier: 50749756671366
• UDI-Public: 50749756671366
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1