MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU-26; INFANT WARMER

Model Number	HNICU-26
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	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order involved was traced and the functional results were reviewed.It was confirmed that all results were found within the specification.We are still waiting for defective 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
Temperature readings was coming up to 36°c when the actual readings showed 37.5°c.
Additional Manufacturer Narrative
All samples from the customer lot (#: 54201852) were received at the manufacturing facility, functional test confirmed that all units were found within the tolerance.Complaint log of the last two years confirmed a total of 18 complaints for the family product of: fhnicu-25, hnicu-26, vhnicu-37, hnicu-37.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, 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: HNICU-26
• 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: 12220788
• Report Number: 9613793-2021-00015
• Device Sequence Number: 4136965
• Product Code: FMT
• UDI-Device Identifier: 00749756032384
• UDI-Public: 00749756032384
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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-26
• Device Lot Number: 54201852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1