MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND INVOS; OXIMETER, TISSUE SATURATION

Model Number	5100C
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cerebral and splanchnic tissue oxygenation are significantly affected in premature infants with ductal-dependent congenital heart disease; anastasiya mankouski, md, timothy m.Bahr, md, katherine l.Braski, md, kimberlee weaver lewis, rn, and mariana c.Baserga, md; the journal of pediatrics: clinical practice, volume 14, december 2024, 200126, https://doi.Org/10.1016/j.Jpedcp.2024.200126 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the literature source, a prospective observational study was conducted to assess cerebral and splanchnic oxygenation in premature infants with prostaglandin dependent congenital heart disease using near-infrared spectroscopy.Nirs (near-infrared spectroscopy) measurements were obtained using the device.Probes were placed on the forehead and on the abdomen to measure splanchnic and cerebral rso2 values.A total of 24 patients were initially enrolled in the study between (b)(6) 2016 and (b)(6) 2021.However, one control participant was excluded due to nirs device malfunction, resulting in aberrant readings.The final data set included 897 measurements from 23 participants.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21143406
• Report Number: 8020893-2025-00003
• Device Sequence Number: 9134269
• Product Code: MUD
• UDI-Device Identifier: 10884521185883
• UDI-Public: 10884521185883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: 5100C
• Device Catalogue Number: 5100C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown