MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	DLCS08651-03
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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
An incident was reported involving a unit experiencing internal component issues.The unit emitted a smoke smell, indicative of a burning internal component, and was functioning intermittently.Additionally, the power cord was found to be disconnected from the unit, failing to establish a proper connection.As part of troubleshooting, the unit was turned off to prevent further complications.No visible smoke was observed, and no power surge occurred during the event.No patient was involved in the incident.
Additional Manufacturer Narrative
Additional information:g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the handle was replaced with a 3d print and showed signs of ingress at the housing screws functional testing found that the device was not connected to external power due to the potential thermal event.The device was opened and inspected, the device was verified to have dried ingress on the ac-dc pcba as well as dried ingress and shorting visible on the dc-dc pcba.Corrosion was also found within the cable's connector for the ac-dc pcba.It was reported that a unit had an internal component producing a smoke smell with possible internal component burning, was working intermittently, and the power cord was pulled out of the unit and not making a connection.The issue was observed during testing and maintenance.The unit was turned off as a troubleshooting step.No smoke was seen and no power surge was experienced.There was no visible physical damage, and no burnt marks were found on the prongs the reported issue was confirmed.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235 ; IS 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235 ; IS 91235
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22975340
• Report Number: 8044004-2025-00014
• Device Sequence Number: 12996278
• Product Code: CCK
• UDI-Device Identifier: 10884521771697
• UDI-Public: (01)10884521771697(17)460222
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: DLCS08651-03
• Device Catalogue Number: DLCS08651-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown