MAUDE Adverse Event Report: AURIS HEALTH, INC. MONARCH PLATFORM; BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES

Model Number	MON-000005-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a successful diagnostic procedure using the monarch bronchoscopy system, the patient reported having hypoxia which is a pre-existing condition that is attributed to medical history of copd.The patient was hospitalized and supplemental oxygen (3l 02) was given and released the following day.No issues were reported regarding the monarch system.Thoughts?.
Event or Problem Description
It was reported that after a successful diagnostic procedure using the monarch bronchoscopy system, the patient reported having hypoxia which is a pre-existing condition that is attributed to medical history of copd.The patient was hospitalized and supplemental oxygen (3l 02) was given and released the following day.No issues were reported regarding the monarch system.
Additional Manufacturer Narrative
Based on the information available for this complaint, the root cause of the reported event is related to a known and documented inherent risk.The reported event will continue to be monitored through regular complaint trend review.B5 description: it was reported that after a successful diagnostic procedure using the monarch bronchoscopy system, the patient reported having hypoxia which is a pre-existing condition that is attributed to medical history of chronic obstructive pulmonary disease (copd).The patient was hospitalized and supplemental oxygen (3l 02) was given and released the following day.No issues were reported regarding the monarch system.

• Brand Name: MONARCH PLATFORM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES
• Manufacturer (Section D): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA 94065
• Manufacturer (Section G): AURIS HEALTH, INC.; 150 shoreline drive; redwood city CA
• Manufacturer Contact: andria smith ; 150 shoreline drive; redwood city, CA 94065 ; 5745510671
• MDR Report Key: 17687075
• Report Number: 3014447948-2023-00020
• Device Sequence Number: 6116774
• Product Code: EOQ
• UDI-Device Identifier: B634MON000005010
• UDI-Public: +B634MON000005010/16D20210706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MON-000005-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American