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

Model Number 8401

Device Problem Defective Alarm (1014)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that the low priority occlusion alarm kept going off.No patient involvement was reported.

Manufacturer Narrative

Other, other text: device evaluation- the monitor was received for evaluation, a visual inspection indicated that the tamper seal was broken.Upon power up, the device indicated an occlusion error.Inspecting the internal components found a kinked tube.Replacing the tube resolved the error.Root cause can be liked to the kink tubing, but causation was unable to be determined.

Event Description

Additional information was received indicating the issue occurred mid january 2022 while in use with a patient.There were no adverse effects to the patient and the monitor was replaced to resolve.

Event Description

Additional info received via email 23-apr-2022.Event date updated.No adverse effects.Event occurred while patient was being monitored and was replaced.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.He smaller tube connected to the carbon dioxide ( c02) bench was found kinked.The technician visually inspected and swap parts.After powered on the device returned 8401 monitor and there was an occlusion error.Internal inspect the monitor, found the smaller tube by the restrictor near the bench kinked.The kink tubing would cause an occlusion.A good known test tube was swapped.Performed flow rate and the monitor was reading a flow rate of 93 milliliter (ml)/min (spec: 120 +/-20 ml/min).The restrictor was swapped with a test restrictor and the flow increased to 135 ml/min.The tamper sticker was found tampered.The reported issue was confirmed.The root cause of the report issue was found to be kink tubing caused by the user.The technician replaced tubing kit and restrictor.

• Brand Name: CAPNOCHECK II, MODEL 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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14135052
• MDR Text Key: 289432251
• Report Number: 3012307300-2022-06503
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2023

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 Operator: Health Professional
• Device Model Number: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/20/2022; 03/09/2023
• Supplement Dates FDA Received: 05/18/2022; 03/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1