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

Model Number 8400D

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that half the screen works on the device.No patient injury was reported.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no physical damage on device.Functional testing found half the liquid crystal display (lcd) was missing.The root cause of the reported issue was found to be customer damaged lcd.Replaced the lcd and the device passed all functional testing.D5 and e4 are unknown, no information provided to date.Additional event information received indicating no patient involvement.

Event Description

Additional information was received which included the event date and there was no patient involvement.Event occurred during inspection.

• Brand Name: BCI CAPNOCHECK II, MODEL 8400
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15164018
• MDR Text Key: 304627533
• Report Number: 3012307300-2022-14656
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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: 8400D
• Device Catalogue Number: 8400D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1