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

Model Number	9004051
Medical Device Problem Codes	Device Alarm System (1012); Battery Problem (2885)
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.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found a damaged sample line.Functional testing found reported problem was verified.Occlusion was present on power up, inspected the rear sample line and it was damaged, sample line was replaced and the occlusion error was no longer present.The battery did not pass the battery life test so it was replaced and now passes the battery life test.The root cause of the reported alarm issue was found to be the rear sample line was kinked from use and handling damage that blocked airflow inside the pneumatics.Kinked and damaged rear tubing is known for resulting from improper handling and twisting of the tubing when removing and connecting the disk filter or from pushing the tubing against other devices during storage or moving.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that the device was showing constant occlusion error and battery dies fast.No patient injury was reported.

• 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: 15349735
• Report Number: 3012307300-2022-17524
• Device Sequence Number: 12138779
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• 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: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2014
• 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