MAUDE Adverse Event Report: ST PAUL BCI CAPNOGRAPHY MONITOR CAPNOCHECK SLEEP; 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's carbon dioxide reading are inaccurate.No patient injury was reported.
Additional Manufacturer Narrative
Other, the customers stated problem of co2 readings inaccurate was verified.The flowrate was checked and it was low but is in spec.10 percent gas was delivered and it read a solid line of 100 mmhg which indicates a non-conforming gas was used to calibrate the monitor.The failure resulted from use of incompatible gas with the monitor during co2 calibration.Monitor was last serviced over 2 years ago in sep 2018 and had passed all functional test.Further dhr review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.Operator of device is unknown.Initial reporter also sent report to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOGRAPHY MONITOR CAPNOCHECK SLEEP
• 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: 15409630
• Report Number: 3012307300-2022-18857
• Device Sequence Number: 6952373
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• 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: 03/23/2021
• 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
• Date Device Manufactured: 02/20/2014
• 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