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

Model Number	8400D
Medical Device Problem Codes	Device Alarm System (1012); Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The monitor was received for investigation.A visual inspection found the tamper seal intact, and the device had no visual damage.This monitor has been returned the third time consecutively for same issues which could not be confirmed each time.The main board was replaced as a preventative measure.A device history report (dhr) review was not relevant because the results of the complaint investigation did not indicate a problem with the initial manufacture or prior repair of the device.No root cause could be determined as the complaint could not be confirmed.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 or Problem Description
It was reported that a c-sum error was displayed.Device would not boot up and kept flashing new co2 sensor.No patient injury was reported.

• Brand Name: CAPNOCHECK MONITOR II 8400
• 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: 15326297
• Report Number: 3012307300-2022-16893
• Device Sequence Number: 17763440
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/31/2022

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: 03/26/2021
• 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: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2012
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown