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

Model Number	CNN/SNN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, a preterm baby who was born on 29+1 weeks, was transferred to nicu, and she was recruited to a study where she had additional monitoring with the device.The sensor was taken off once a day to air the skin under it and a specific adhesive remover was used to make sure that the baby¿s skin would not be harmed.But on the third day, it was noticed that there were two dark spots on her forehead, right where the sensor had the electrodes, and those spots turned out to be necrotic.The monitoring was finished at that point and the sensor was removed altogether, and the baby¿s skin was tended with medical honey in accordance with the nicu¿s instructions.It took quite a few weeks for the skin to heal, but is now ok.
Additional Manufacturer Narrative
Correction: d3 additional information: d4, d8, g1, g3, h6 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.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway 20023 ; EI 20023
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway 20023 ; EI 20023
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 10121142
• Report Number: 2936999-2020-00402
• Device Sequence Number: 11340244
• Product Code: MUD
• UDI-Device Identifier: 20884521106229
• UDI-Public: 20884521106229
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNN/SNN
• Device Catalogue Number: CNN/SNN
• Device Lot Number: A181808X
• 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: 04/29/2020
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 MO
• Patient Sex: Female