MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) MICROSTREAM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	010579
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted to the nicu due to neonatal distress.The infant was placed on invasive ventilator support with continuous monitoring of end-tidal carbon dioxide (etco2) levels.At approximately 5:00 pm, etco2 readings were within normal limits.However, during a routine check at 9:00 pm, the attending physician found that the monitor no longer displayed etco2 readings.Reconnection of the sampling tube did not resolve the issue.The sampling tube was then replaced with a new one, after which normal etco2 monitoring resumed.The infant's vital signs remained stable, and no adverse outcomes occurred.
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
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22937495
• Report Number: 9681384-2025-00936
• Device Sequence Number: 9800892
• Product Code: CCK
• UDI-Device Identifier: 20884521551982
• UDI-Public: (01)20884521551982(11)210827(10)21H1081JZ(20)21
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181467
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 010579
• Device Catalogue Number: 010579
• Device Lot Number: 21H1081JZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 08/27/2021
• 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-1377-2025
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male