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

Model Number	9004003
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The product was received for evaluation.Visual and functional testing were performed.The tube was found kinked, two tubing from valve was found smashed.The reported problem was confirmed.The root cause of the reported issue was found to be that the internal tubes were routed incorrectly caused by manufacturing.The technician replaced all smashed and linked tubes.Quality specialist sme noted, further investigation determined that the piece of the tubing attached to the end of another tubing that connected to valve 1 on the main board was cut too short, leaving no slack in the tubing for flexibility.The kink was right above the barbed fitting after being tied down in the tubing bundle.It was trimmed to 1/2 inches instead of the 3/4 inches recommended by procedures.The device passed final functional test.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported there was an error of occlusion.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK PLUS SLEEP CARBON DIOXIDE DETECTOR
• 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; al kazemi bldg., #10, 3rd floo; minneapolis, MN 55442
• MDR Report Key: 15361363
• Report Number: 3012307300-2022-17851
• Device Sequence Number: 5825618
• Product Code: CCK
• UDI-Device Identifier: 10610586036415
• UDI-Public: 10610586036415
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 9004003
• Device Catalogue Number: 9004003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• 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: 05/23/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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