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

Model Number	DLCS08651-03
Medical Device Problem Codes	Device Alarm System (1012); Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, prior to use, the monitor failed to fully power on.The screen did not display any images, and only one amber light turned on.The monitor did not produce any alarming sounds.It was power cycled, and a new battery was used to isolate the failure.This was an out-of-box failure.There was no patient involvement.
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: g3, h3, h6 correction: g2 (health professional) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no obvious signs of defects or damaged components.Functionally, the unit was disassembled, and the main board was inspected.All connections were unplugged and checked, with no damaged or loose connections found.The unit was reassembled, and upon reassembly, it powered on without any issues or error messages.No battery was received with the unit.The issue was resolved by installing a new battery, the software version was verified to be 9.3, and the co2 board was recalibrated.It was reported that the monitor failed to fully power on.The screen did not display any images, and only one amber light turned on.The monitor did not produce any alarming sounds.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 22860657
• Report Number: 8044004-2025-00013
• Device Sequence Number: 15767546
• Product Code: CCK
• UDI-Device Identifier: 10884521771697
• UDI-Public: (01)10884521771697(17)460806
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 08/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2018
• 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