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

Model Number	8401
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received to perform an investigation.A visual inspection of the capnograph system found no physical damage.Functional testing was performed using alarm setting, flow rate and c02 testing.During testing, the alarm issue was duplicated; however, co2 functions were found to be operating as intended.The monitor alarmed based on the highest alarm limit set by the user which just needed to be increased per instructions in the operation manual to resolve the issue.A device history record (dhr) review was not performed because the results of the complaint investigation did not indicate a problem with the initial manufacture or prior repair of the device.This was the first repair for the device per repair records.The problem source was determined to be user interface.The alarm limit setting was adjusted.In addition, the flow rate was found to be higher than specification and the resistor was replaced to resolve the problem.Operator of device is unknown.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 alarmed at 76 mmhg (millimeters of mercury).No patient injury was reported.

• Brand Name: BCI CAPNOCHECK II CAPNOGRAPH SYSTEM
• 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: 15402549
• Report Number: 3012307300-2022-18709
• Device Sequence Number: 5006953
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• 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): 09/12/2022

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: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2018
• 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