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

Model Number	MAXN
Medical Device Problem Codes	Device Alarm System (1012); Incorrect Measurement (1383); Failure to Analyze Signal (1539); Low Readings (2460)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that oxygen saturation was inaccurate during use.The operator followed instructions, using an unopened device within its expiration date, and connected the pulse oximeter sensor to the patient finger secured with self-adhesive type tape.After 20 hours, the nurse found the patient unconscious, and adjusting the sensor did not yield readings.Monitoring results were inconsistent, posing a significant safety hazard.The nurse initiated rescue, performed a bedside oxygen saturation check, and provided pressurized oxygen via mask.The reported spo2 reading was 75%, whereas the blood gas results showed 96% saturation.After replacing the pulse oximeter sensor, monitoring returned to normal and the patient¿s condition stabilized.There was no audible and visual alarms triggered.
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.
Additional Manufacturer Narrative
Additional information: h6.Correction: b7.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: 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: 24719989
• Report Number: 9610849-2026-00079
• Device Sequence Number: 6110182
• 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,Followup
• Report Date (Section B): 04/06/2026

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: 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: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male