MAUDE Adverse Event Report: COVIDIEN LLC MICROSTREAM ADVANCE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	MVAIL
Medical Device Problem Codes	Low Readings (2460); Filtration Problem (2941)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during capnography monitoring, the device showed low readings due to a faulty co2 sampling line.The product was not tested prior to patient use, other than confirming an etco2 trace on the philips monitor.Initially, the end-tidal co2 trace appeared normal, but it suddenly resembled an obstructed airway, with the waveform distorted and the etco2 decreasing from 33 to 16.The patient¿s condition did not change¿tidal volume and oxygenation remained stable, and the endotracheal tube was correctly positioned.After replacing the sampling line, a normal trace and waveform were observed, with an etco2 value of 37.When malfunctioning, the device displayed an abnormal trace consistent with an obstructed airway pattern, with values between 14 and 17.Once replaced with a new device, the etco2 trace returned to normal at 37.It is unknown whether any patient symptoms or complications were associated with this event.
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.

• Brand Name: MICROSTREAM ADVANCE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN LLC; 200 medtronic dr; lafayette CO 80026
• Manufacturer (Section G): COVIDIEN LLC; 200 medtronic dr; lafayette CO 80026
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25111197
• Report Number: 2936999-2026-00177
• Device Sequence Number: 9219196
• Product Code: CCK
• UDI-Device Identifier: 20884521761909
• UDI-Public: (01)20884521761909(11)241128(10)C241102062(20)16
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: MVAIL
• Device Catalogue Number: MVAIL
• Device Lot Number: C241102062
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 11/28/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1384-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown