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

Model Number	9004050
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was reading inaccurately.No patient injury was reported.
Additional Manufacturer Narrative
No additional information was received.The device was returned for evaluation.The front bezel had a crack at the screw location and crack lens.Functional tests were performed: power on off unit, swap parts, flow rate test, c02 test; and the reported complaint was verified after inaccurate c02 10% reading and the flow rate was out of specification.This was the first time in for service after about five years in the field and the failure resulted from worn co2 pump mechanism no longer drawing adequate airflow through the pneumatics and causing the co2 sensor to drift out of calibration.Root cause could not be determined.The device history record (dhr) review was 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.Device was manufactured in 2016.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOCHECK PLUS
• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15409673
• Report Number: 3012307300-2022-18873
• Device Sequence Number: 5620840
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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
• Device Model Number: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/13/2022
• 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