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

Model Number 8401

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device or prior repair of the device.A product sample was received for evaluation.Visual inspection and functional testing were performed.The technician found that the speaker was loose and pump was dislodged.Functional testing could not confirm the complaint.This device not measure saturation of peripheral oxygen (spo2).The technician tested the flow rate and co2 readings.Both the readings were within the specification.The root cause could not be determined as the reported issue and complaint were not confirmed.Operator of device is unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device was not providing oxygen readings.No patient injury was reported.

• Brand Name: BCI 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15328962
• MDR Text Key: 302939404
• Report Number: 3012307300-2022-17073
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1