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 calibrated before returning to floor and he is not getting any readings.No adverse patient effects were reported.

Manufacturer Narrative

H10: investigation findings: the reported complaint was verified after test the flow rate on the returned 9004050 monitor and there was no flow rate.When the monitor has no flow rate the monitor would not be able to calibrate the c02 due to a leak.Internal inspect the inside of the device, the c02 pump was found with a disconnected tube.The disconnected tube was re-connected and the flow rate increase.Due to the disconnect tube at the c02 pump, the tubing kit will need to be replace as a preventive maintenance.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10829.The report was submitted in error., corrected data: corrected information provided in h10.

• 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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12764043
• MDR Text Key: 280447755
• Report Number: 3012307300-2021-10829
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004050
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1