MAUDE Adverse Event Report: PULMONX CORPORATION CHARTIS CATHETER; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Model Number	G3
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Chartis catheter would not work properly and was not showing any flow on the charits machine.Changed to a new catheter and it worked fine.I attempted to mimic flow after the procedure and it seems as if the air flow sensor is not working properly on this specific catheter.

• Brand Name: CHARTIS CATHETER
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): PULMONX CORPORATION; 700 chesapeake drive; redwood city CA 94063
• MDR Report Key: 13885980
• Report Number: 13885980
• Device Sequence Number: 13820055
• Product Code: CBI
• UDI-Device Identifier: 00811907030928
• UDI-Public: (01)00811907030928(10)505574(17)230623
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2022
• Report Date (Section F): 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G3
• Device Catalogue Number: CHR-CA-12.0
• Device Lot Number: 505574
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/21/2022