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

Model Number	8400D
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was showing a check sum error.No patient injury was reported.
Additional 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 initial manufacture or prior repair of the device the device was returned for evaluation.Visual and functional tests were performed.There was no physical damage observed.The reported problem could not be duplicated.The reported issue could not be confirmed, no problem found.If the initial reporter also sent report to fda is unknown.No product information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CAPNOCHECK II, MODEL 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; 7777 forest lane; minneapolis, MN 55442
• MDR Report Key: 15319450
• Report Number: 3012307300-2022-16668
• Device Sequence Number: 12068922
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8400D
• Device Catalogue Number: 8400D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown