{ "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": "62825447", "event_type": "Injury", "report_number": "3014447948-2023-00031", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20231207", "manufacturer_address_2": "", "pma_pmn_number": "K211493", "date_of_event": "20231110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6282544750", "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": "628", "date_added": "20231207", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20211115", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1366268", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20231207", "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": "", "udi_public": "", "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": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/02/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6282", "patient": [ { "patient_sequence_number": "1", "date_received": "20231207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Low Blood Pressure/ Hypotension", "Asystole", "Cardiac Arrest", "Low Blood Pressure/ Hypotension", "Asystole" ] } ], "distributor_city": "", "date_report": "20240103", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "18284343", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20231110", "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": "340959415", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE SYSTEM LOGS WAS UNABLE TO CONFIRM THE OCCURRENCE OF ANY FAULTS OR ERRORS RELATED TO THE REPORTED ISSUE. SOURCE: S3: 2023-11-10/SYSTEM120106/{42EC9157-4BFA-4FE7-92CE-E6FEA63DBBDC}. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE SYSTEM; THERE WERE NO NON-CONFORMANCES RELATED TO THE ADVERSE EVENT. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED TO BE AN ADVERSE EVENT RELATED TO PATIENT CONDITION." }, { "mdr_text_key": "329956341", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IN A FOLLOW UP CALL THE RESPIRATORY THERAPIST INFORMED THE ACCOUNT MANAGER THAT THE PATIENT HAD PASSED 3-DAYS AFTER THE PROCEDURE. THE RASPATORY THERAPIST REAFFIRMED THE MONARCH SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENTS DECREASE IN HR OR SUBSEQUENT DEATH. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE." }, { "mdr_text_key": "329956342", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "628", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/03/2024" } ] }