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

Model Number	MAXN
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	03/20/2026
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 during use, the oxygen saturation had an inaccurate measurement.The operator followed instructions, using an unopened device within its expiration date, and connected the pulse oximeter sensor to the patient monitor.After 10 hours, the oxygen saturation waveform on the monitor appeared normal, but the displayed value was 79%.The monitoring result was seriously inconsistent with the patient¿s actual condition, leading to abnormal monitoring and posing a significant safety risk.After discovering the issue and reporting it to the physician, bedside blood gas analysis was immediately performed and preparations for endotracheal intubation were made.The bedside blood gas analysis showed an oxygen saturation of 99%.A new pulse oximeter sensor was then used to re-monitor the patient¿s oxygen saturation.After replacing the pulse oximeter sensor, no abnormalities were observed during monitoring, and the patient¿s condition stabilized after monitoring was restored.

• 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: 24858063
• Report Number: 9610849-2026-00091
• Device Sequence Number: 18401273
• Product Code: DQA
• UDI-Device Identifier: 20884522041727
• UDI-Public: (01)20884522041727(17)280630(10)252020160H
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: MAXN
• Device Catalogue Number: MAXN
• Device Lot Number: 252020160H
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 07/21/2025
• 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 Age: 30 YR
• Patient Sex: Male