MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK II, MODEL 8400; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	8400
Medical Device Problem Codes	Incorrect Measurement (1383); Calibration Problem (2890)
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 had a low carbon dioxide (co2) error and the device was unstable during calibration.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.Fluid ingression in the valve and bench was observed.The monitor was powered up and a high/low calibration was performed, it went through the low calibration but did not see the 10% calibration gas and gave a high unstable error.The monitor was opened and orangish brown color fluid went through the tubing to the valve assembly and into the bench.The reported issue of error low co2 and unstable during calibration was duplicated.The technician replaced all required parts to resolve the reported issue.The device passed all the functional test.The root cause of the reported issue was determined to be related to the customer's impact to the device.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOCHECK II, MODEL 8400
• 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: 15320163
• Report Number: 3012307300-2022-16700
• Device Sequence Number: 5518437
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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