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

Model Number	MVIIH
Medical Device Problem Codes	High Readings (2459); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
New information has been received pertaining to the event that the customer found there was no issue with the reported product.This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.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
According to the reporter, during use, the end-tidal carbon dioxide (etco2) was higher than the partial pressure of carbon dioxide (paco2) from the venous blood gas (vbg) draw.It was noted that all modules were calibrated since the yearly scheduled calibration was due.The etco2 readings were corrected per the registered respiratory therapist (rrt) following the calibration.Customer added that after the monitors had co2 recalibrated, the paco2 and etco2 numbers looked good.There was no issue with the filter line.There was no patient injury.Not a complaint.
Event or Problem Description
According to the reporter, during use, the end-tidal carbon dioxide (etco2) was higher than the partial pressure of carbon dioxide (paco2) from the venous blood gas (vbg) draw.It was noted that all modules were calibrated since the yearly scheduled calibration was due.The etco2 readings were corrected per the registered respiratory therapist (rrt) following the calibration.There was no patient 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.

• Brand Name: MICROSTREAM ADVANCE
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19203801
• Report Number: 8044004-2024-00010
• Device Sequence Number: 8021366
• Product Code: CCK
• UDI-Device Identifier: 20884521761985
• UDI-Public: 20884521761985
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: MVIIH
• Device Catalogue Number: MVIIH
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown