MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004051
Medical Device Problem Codes	Unable to Obtain Readings (1516); 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 there is an unstable co2 reading and calibration.No additional information.
Event or Problem Description
It was reported that there is an unstable co2 reading and calibration.No additional information.
Additional Manufacturer Narrative
A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a broken barrel from the filter slot attachment and the tamper seal was broken.Functional testing found a defective c02 bench which caused the unstable c02 reading and calibration error.The root cause of the reported issue was found to be a malfunctioning co2 sensor from wear of 20 years usage.The monitor was last serviced over 6 years ago in jan 2016 and had passed all functional tests per ro# 656519.Further device history record (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.

• Brand Name: BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER
• 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: 13595016
• Report Number: 3012307300-2022-04134
• Device Sequence Number: 20133607
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/01/2022

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: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2001
• 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