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

Model Number HNICU-37

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

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 Description

Temperature readings were not accurate on the new style hnicu probe.

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: NENONATAL TEMPERATURE SKIN SENSOR
• Type of Device: 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: 11855880
• MDR Text Key: 252385338
• Report Number: 9613793-2021-00012
• Device Sequence Number: 1
• Product Code: FMT
• UDI-Device Identifier: 00749756671361
• UDI-Public: 00749756671361
• Combination Product (y/n): N
• PMA/PMN Number: K200319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNICU-37
• Device Lot Number: 54207322
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1