MAUDE Adverse Event Report: ST PAUL BCI; CARBON DIOXIDE GAS ANALYZER.

Model Number	9004000
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was returned for investigation.The device was turned on and tested and the issue was confirmed.After changing the settings to the correct device settings, the issue was resolved.Root cause was traced to the user.Dhr review not done due to issue being traced to user.
Event or Problem Description
It was reported that occlusion was suspected.The issue was discovered during inspection with no patient involved.
Additional Manufacturer Narrative
One unit was returned for investigation.The device was turned on and tested and the issue was confirmed.After changing the settings to the correct device settings, the issue was resolved.Root cause was traced to the user.Dhr review not done due to issue being traced to user.

• Brand Name: BCI
• Common Device Name: CARBON DIOXIDE GAS ANALYZER.
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12698173
• Report Number: 3012307300-2021-10248
• Device Sequence Number: 4613894
• Product Code: CCK
• UDI-Device Identifier: 10610586036811
• UDI-Public: 10610586036811
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 9004000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown