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

Model Number	MAXFAST
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Cyanosis (1798); Low Oxygen Saturation (2477)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury
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 a patient in the icu was being monitored with a forehead spo2 probe and was transported to the endoscopy suite for a procedural sedation and ercp procedure.During transport, throughout the procedure, and following the procedure, the spo2 probe intermittently failed to provide a reliable reading.The waveform was poor and did not correlate with the arterial line readings.The signal quality worsened during and after the procedure.Due to the unreliable readings, the patient¿s oxygenation was assessed using clinical signs such as gum color and chest rise.A nasal spo2 probe and cable were brought during transport and briefly trialed during the procedure; however, no waveform or numeric reading was obtained, and the device was not used further.Throughout the procedure the patient¿s blood pressure remained adequate, with systolic blood pressure ranging between 90 and 110 mmhg, and central perfusion appeared sufficient.During transport back to the icu, the forehead spo2 probe displayed readings between 83¿88% with a poor waveform.At that time the patient was observed to be centrally cyanotic.The patient continued breathing without observed apnea or snoring.A respiratory therapist inserted an oropharyngeal airway and performed a jaw thrust maneuver, but no improvement was noted.Upon return to the icu, the spo2 probe continued to provide unreliable readings.A device was inserted and the patient was ventilated using bagging by the respiratory therapist due to the lack of a reliable spo2 value and waveform.An arterial blood gas (abg) was obtained to determine the patient¿s oxygenation status and based on the abg results the patient was subsequently started on bipap therapy.

• 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: 25675280
• Report Number: 9610849-2026-00137
• Device Sequence Number: 11961341
• Product Code: DQA
• UDI-Device Identifier: 10884521815360
• UDI-Public: (01)10884521815360(17)290131(10)260540178H(20)06
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: MAXFAST
• Device Catalogue Number: MAXFAST
• Device Lot Number: 260540178H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/01/2026
• Date Device Manufactured: 02/13/2026
• 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
• Patient Sex: Unknown