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

Model Number 8401

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.Visual inspection found loose parts inside.The monitor was powered up and the flowrate was 0 ml/min and was unable to create an occlusion.The monitor was opened and the whole top of the pump was laying loose inside the monitor along with liquid crystal display (lcd) screws that were stuck in the pump foam.The investigation determined that the failure was a result of impact sustained by the monitor during use and handling.The operation manual has a warning section that indicates any monitor that has been dropped or damaged, should be inspected by qualified service personnel, prior to use, to insure proper operation.A device history record (dhr) review was not applicable or relevant because the results of the complaint investigation did not indicate a problem with the initial manufacture or prior repair of the device.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).

Event Description

It was reported that an error co2 sensor occurred.No additional information available.

• Brand Name: CAPNOCHECK II CAPNOGRAPH SYSTEM
• 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: 15312103
• MDR Text Key: 305366082
• Report Number: 3012307300-2022-16535
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• 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: Distributor
• 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: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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