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

Model Number	9004050
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Poor Quality Image (1408); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device is unknown; no additional information has been received to date.The device was returned for evaluation.It was noted that the absorber and backlight cable assembled incorrectly by customer, brass insert on top case damaged.Functional test was performed.Ten percent gas was applied to the monitor and it read 69 mmhg, performed a hi/lo calibration; the readings were right on for the days pressure.As for the screen flickering and display dim, no problem was found; screen was bright as a new one and no flickering was present.The back light cable was replaced as a preventive measure.The problem was deemed due to the device being out of calibration.Root cause was deemed to be user interface.The failure resulted from user tampering with the monitor resulting in incorrect assembly and the co2 sensor to drift out of calibration.Monitor was last serviced in february 2019 and had passed all functional tests.Further device history record (dhr) review was not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.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 screen was flickering, display was dim, and readings were off.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK PLUS
• 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: 15409646
• Report Number: 3012307300-2022-18865
• Device Sequence Number: 6952889
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• 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: 09/13/2022
• 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