MAUDE Adverse Event Report: ST PAUL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 9004050

Device Problem Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a smiths medical capnograph is reading zero during patient study. No adverse patient effects were reported.

• Brand Name: BCI
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12808353
• MDR Text Key: 280771473
• Report Number: 3012307300-2021-11227
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No