MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK PLUS SLEEP CARBON DIOXIDE DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number 9004

Device Problems Device Alarm System (1012); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

No product sample was received; therefore, no visual and functional testing could be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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 an occlusion was displayed, replaced filter, trap, absorber and braided tube.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK PLUS SLEEP CARBON DIOXIDE DETECTOR
• 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: 15334229
• MDR Text Key: 305539127
• Report Number: 3012307300-2022-17163
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1