MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 9004050

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The device was received for evaluation.Visual and functional testing were performed.Visual inspection found the tamper seal was broken and the device was dirty.Functional testing found complaint was verified.The root cause of the reported issue was found to be tamper sticker found broken and co2 sleep pump was failing; co2 pump should be replaced.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 the product is not reading correctly and the pump inside is making more noise than usual.No patient injury was reported.

• Brand Name: BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER
• 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; attn: pharmacy receiving rm 07; minneapolis, MN 55442
• MDR Report Key: 15328413
• MDR Text Key: 304924408
• Report Number: 3012307300-2022-17059
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• 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: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1