{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "574551-0", "event_type": "Injury", "report_number": "3014447948-2022-00027", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220906", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20220818", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "574551-067", "noe_summarized": "1", "manufacturer_contact_l_name": "SMITH", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "574", "date_added": "20220906", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20220413", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2368011", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220906", "brand_name": "MONARCH PLATFORM", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES", "manufacturer_d_name": "AURIS HEALTH, INC.", "manufacturer_d_address_1": "150 SHORELINE DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "REDWOOD CITY", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94065", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94065", "device_operator": "HEALTH PROFESSIONAL", "model_number": "MON-000006", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "B634MON0000060", "udi_public": "+B634MON0000060/16D20220413", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/13/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250731", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5745", "patient": [ { "patient_sequence_number": "1", "date_received": "20220906", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "High Blood Pressure/ Hypertension", "Cardiac Arrest", "High Blood Pressure/ Hypertension" ] } ], "distributor_city": "", "date_report": "20221013", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "15361952", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220822", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "AURIS HEALTH, INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "299294391", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO A MONARCH BRONCHOSCOPY PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL, THE PHYSICIAN BEGAN THE BIOPSY. DURING THE PROCEDURE THE ANESTHESIOLOGIST NOTED THE PATIENT WAS NOT DOING WELL AND THE PATIENT WENT INTO CARDIAC ARREST. THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION AND ABORTED THE CASE. THE PATIENT WAS INTUBATED. ON (B)(6) 2022 THE PHYSICIAN REPORTED 3 X-RAYS WERE TAKEN AND THERE WAS NO SIGN OF A PNEUMOTHORAX. THE PATIENT HAS RECOVERED. THERE WERE NO ISSUES OR FAULTS WERE REPORTED FROM THE SYSTEM." }, { "mdr_text_key": "299294412", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "332616462", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THERE WERE NO DEVICE MALFUNCTIONS REPORTED FROM THE PROCEDURE. NO FURTHER INVESTIGATION WAS PERFORMED AS THERE IS INDICATION THAT THE REPORTED EVENT WAS NOT DUE TO DEVICE MALFUNCTION AND ALSO IT HAS BEEN STATED THAT THERE ARE NO ALLEGATIONS TOWARDS THE MONARCH. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SYSTEM 120137 AND THERE WERE NO NON- CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE. G4: 510(K) K211493." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "574", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/13/2022" } ] }