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

Model Number	8401
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One product sample was received in good physical condition.The reported problem was duplicated.The monitor was powered with no error but after attaching a filter an occlusion error was present and would not go away.Opened the monitor and the occlusion error was gone, inspected the tubing going to the bench and they both looked kinked.After replacing the tubing for both, the occlusion error was no longer present.The root cause of the reported issue was found to be the weight of the restrictor pushing the small diameter tubing against the co2 bench nozzle as the housing closes.The device history record (dhr) review is 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.E4 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).
Event or Problem Description
It was reported that an error occlusion was found upon testing.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; minneapolis, MN 55442
• MDR Report Key: 15334217
• Report Number: 3012307300-2022-17160
• Device Sequence Number: 6889720
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/01/2022
• 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