MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU -37 - 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); Output Problem (3005)
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 ((b)(4)) was reviewed and confirmed 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 complaints 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 (b)(4) samples tested and resulted all pass qc functional test.During the period of (b)(6) 2020 - (b)(6) 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 received, this report will be updated.
Event or Problem Description
During skin rounds in our nicu the probe was brought to attention with concerns on the feel and functionality.Both the nurse and wound care nurse noticed that this was a different temp probe that has been used with the giraffe isolette.The 'wire' was kinky and did not lay as flat as in the previous product.We also noted that the blue tip covering the sensors did not seem to be as 'thick' as compared to the previous one with a 'white' end.This could have been because we really could not see the sensors through the 'white' tip, but the product felt as if you could feel those sensors easily.The nurse had stated that she had went to retrieve another one because she was not sure if the sensor was accurately getting a good temp and had to apply two sensor probe covers over the tip.

• Brand Name: HNICU -37 - NEONATAL TEMPERATURE SKIN SENSOR
• 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, cri
• MDR Report Key: 11518761
• Report Number: 9613793-2021-00010
• Device Sequence Number: 16963038
• 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,health
• Initial Reporter Occupation: Nurse
• 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: No Information
• 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