{ "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. 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NO ISSUES WERE REPORTED REGARDING THE MONARCH SYSTEM." }, { "mdr_text_key": "322697736", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "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?" } ], "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": "10/05/2023" } ] }