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

Model Number	9004000
Medical Device Problem Codes	Inappropriate Waveform (2536); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The rear sample line was damaged.Flowrate test and hi/lo calibration testing were done and the reported problem was duplicated.The stated problem of: not giving proper wave form/ pump starts and stops/ eval ac adapter, was verified.For the wave form problem and pump starts and stops, the pump flow was slow and the pump was very loud and grinding.The pump was replaced and the monitor passed the hi/lo calibration and the wave form was steady with a flowrate within specification.As for the evaluation on the ac cord, the strain relief was damaged and had a steady 24 volts.The problem was caused by a defective co2 pump.Malfunctioning co2 pump mechanism no longer drawing adequate airflow from wear of age.Due to wear of life the co2 pump has reached the end of its useful life after 6 years of operation.The device history record (dhr) review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.This was the first time the device was received for service after 6 years in the field and the failure resulted from worn co2 pump mechanism due to wear of age.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the device was not giving the proper wave form, the pump starts and stops, and the ac adaptor was worn.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: 15422665
• Report Number: 3012307300-2022-19201
• Device Sequence Number: 4749987
• Product Code: CCK
• UDI-Device Identifier: 10610586036811
• UDI-Public: 10610586036811
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/14/2022

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: 9004000
• Device Catalogue Number: 9004000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• 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: 09/14/2022
• 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