MAUDE Adverse Event Report: ST PAUL BCI; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004000
Medical Device Problem Codes	Failure to Cycle (1142); Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) - the high calibration is unstable and calibration is starting to take longer.The second problem stated by staff is that it does not calculate etco2 intermittently, where they can see the breaths but there is no etco2 calculation.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Investigation determined that the tamper seal was broken and non-conforming outside sample tubing was installed indicating the monitor had been tampered with.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10676.The report was submitted in error.

• Brand Name: BCI
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12749040
• Report Number: 3012307300-2021-10676
• Device Sequence Number: 11924152
• Product Code: CCK
• UDI-Device Identifier: 10610586036811
• UDI-Public: 10610586036811
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2023

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
• Device Catalogue Number: 9004000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 05/02/2023
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/04/2022; 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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