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

Model Number 8400

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the end title part did not work.There was an error of co2 not stable.No patient injury was reported.

Manufacturer Narrative

A sample was received to perform an investigation.Visual inspection found the device had no damage.The flowrate was measured out at 112 ml/min and would not perform a hi/lo calibration, and the monitor would not see the gas.The reported problem was verified.The co2 bench was replaced and resolved the issue.The cause of the reported problem was related to a defective co2 bench due to wear.This unit was sold in 2010 and this was the first time for repair.The co2 bench has reached the end of its useful life after nearly 10 years of operation.As a result, a fault could not be assigned.Operator of device 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 MONITOR II 8400
• Type of Device: 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: 15312109
• MDR Text Key: 305268274
• Report Number: 3012307300-2022-16537
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1