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

Model Number	SAFB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 5100c-eu; 5100c-eu eu 5100c monitor assy x1 (serial# (b)(6).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
It was reported that the patient was in intensive care unit (icu) and part of a research study, there was a skin integrity on the forehead and the sensors were permanently removed.Patient experienced deep tissue injury on the left forehead and stage two ulcers on the right forehead.The study probes was applied, patient critically ill on multiple vasopressors throughout his admission.Study probes removed once ulcers noted.The patient was present alive and on life support due to their preexisting condition.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22785139
• Report Number: 8020893-2025-00185
• Device Sequence Number: 21287840
• Product Code: MUD
• UDI-Device Identifier: 20884521104225
• UDI-Public: 20884521104225
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: SAFB
• Device Catalogue Number: SAFB
• 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: 07/23/2025
• Initial Report FDA Received Date: 08/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown