MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

Model Number	MAXAI
Medical Device Problem Codes	Device Alarm System (1012); Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 unit's arrest page alarm went off and the patient had an adhesive finger pleth attached to her forehead.It was advised that forehead pleths were not licensed for use on the forehead, as it was resulting in unreliable readings.There appeared to be no mention of forehead use on the packaging or in the instructions included in the box.The diagrams provided only demonstrate proper usage on the finger.It was unknown if there was any patient complications as a result of the event.
Additional Manufacturer Narrative
Correction: b5, h6 (rfr code (no alarm - removed) additional information: e1 (facility name and address), g3, h6 (rfnr) 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 arrest page went off even though the sensor was still attached to the patient's forehead.It was found that the sensor was applied on forehead instead of the finger which led to unreliable readings.No patient outcome was reported.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22770781
• Report Number: 9610849-2025-00030
• Device Sequence Number: 18463876
• Product Code: DQA
• UDI-Device Identifier: 20884522040072
• UDI-Public: 20884522040072
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012891
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: MAXAI
• Device Catalogue Number: MAXAI
• Device Lot Number: 250550157H
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 02/24/2025
• 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
• Patient Sex: Unknown