MAUDE Adverse Event Report: ST PAUL PATIENT MONITORING CAPNOGRAPHY; CAPNOCHECK II, MODEL 8400

Model Number	8400
Medical Device Problem Code	Incorrect Measurement (1383)
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 etco2 reading is not accurate.In addition, the occlusion message and alarm did not stop after removal of patient attachment and moisture filter.No patient harm was reported.
Additional Manufacturer Narrative
The device was received for evaluation.Visual and functional testing were performed and the reported issue was confirmed.During visual inspection, no damage was found on the device.During functional testing, the reported issue was duplicated, the small tube from valve to c02 bench was kinked.The confirmed issue of readings not accurate was due to the tube not routed correctly during manufacture.The occlusion alarm was due to the kinked tube.The tube was replaced and the device passed functional testing.A manufacturing device history review (dhr ) was performed and non conformances were identified and rework was performed.The root cause for the confirmed issue has been traced to manufacturing.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: PATIENT MONITORING CAPNOGRAPHY
• Common Device Name: CAPNOCHECK II, MODEL 8400
• 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: 15409642
• Report Number: 3012307300-2022-18861
• Device Sequence Number: 6952888
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: 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: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• 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: 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