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

Model Number 9004050

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device or prior repair of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.No physical damage was observed.The reported device was put on the carbon dioxide (co2) simulator for testing.The device was getting high end-tidal co2 (etco2) reading of 79mmhg.However, the range for testing was set between 70 to 76 mmhg.The technician was able to duplicate the reported issue of high readings.The technician performed the high/low calibration to resolve the reported issue.After calibration, the technician was able to get the etco2 reading of 73 mmhg, which is within specifications.The root cause of the reported issue was determined to be related to the customer/ user interfacing with the product in a manner inconsistent with the instruction for use (ifu).The ifu in the operator manual recommends the user perform high/low calibration every 6 months to ensure that the etco2 and o2 measurements are accurate.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

Event Description

It was reported that there was an high readings issue with the reported device.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK PLUS
• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 1195 w fremont ave; minneapolis, MN 55442
• MDR Report Key: 15326684
• MDR Text Key: 305346391
• Report Number: 3012307300-2022-16925
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1