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

Model Number	8401
Medical Device Problem Code	Device Alarm System (1012)
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 was showing occlusion constant error.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found tamper seal removed, a broken off component from main board in bag, top port clogged and pump dislodged.Functional testing found no occlusion error was present at power up.Opened the monitor and inspected the tubing going to bench and it was a little kinked, but the pump had no flowrate, so the pump was replaced and now the occlusion error was present.It was found that the top filter port was clogged with some white substance that couldn't be removed.The root cause of the reported issue was found to be a result of the user interfacing with the product in a manner inconsistent with the operation manual.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 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: 15334279
• Report Number: 3012307300-2022-17171
• Device Sequence Number: 6861716
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Device Model Number: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• 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: 04/20/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2018
• 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