MAUDE Adverse Event Report: ST PAUL CAPNOCHECK PLUS CAPNOGRAPH AND DIGITAL OXIMETER; ANALYZER, GAS, CARBON DIOXIDE, GASEOUS PHASE

Model Number	9004005
Medical Device Problem Code	Device Alarm System (1012)
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 giving an occlusion error.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.The product was received for evaluation.Visual and functional testing were performed.Visual inspection found the device was in excellent physical condition and the tamper seals were intact.The reported complaint was verified after power up of the monitor as an occlusion error appeared.The root cause was found to be kinked tubing.The technician replaced the tubing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: CAPNOCHECK PLUS CAPNOGRAPH AND DIGITAL OXIMETER
• 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: 15337996
• Report Number: 3012307300-2022-17337
• Device Sequence Number: 15065537
• Product Code: CCK
• UDI-Device Identifier: 10610586036842
• UDI-Public: 10610586036842
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: 9004005
• Device Catalogue Number: 9004005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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