{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 7625 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "10009002", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20190419", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "report_date": "20200421", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "472141", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200429", "brand_name": "ALLURA XPER WITH FLEXVISION", "generic_name": "SYSTEM, X-RAY, ANGIOGRAPHIC", "manufacturer_d_name": "PHILIPS HEALTHCARE", "manufacturer_d_address_1": "3721 VALLEY CENTRE DRIVE, SUITE 500", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN DIEGO", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92130", "device_operator": "0", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "IZI", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, X-Ray, Angiographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1600", "device_class": "2" } } ], "product_problems": [ "No Display/Image", "Defective Device" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "22265 DA", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200421", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200429", "manufacturer_contact_city": "", "mdr_report_key": "10009002", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200421", "manufacturer_name": "", "report_source_code": "User Facility report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189322711", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS PATIENT WAS ON CATH LAB TABLE, AND AS WE WERE ABOUT TO START THE PROCEDURE, X-RAY DIDN'T WORK. A SOFT AND A HARD REBOOT WAS DONE WITHOUT ANY IMPROVEMENT. PHILLIPS WILL BE CALLED FOR NOTIFICATION. PATIENT WAS TRANSFERRED TO ANOTHER LAB TO PERFORM THE CASE. REPLACED THE DCPS POWER SUPPLY IN THE B-CABINET - RECHECKED EVERYTHING AND SYSTEM WAS STABLE. PHILIPS SERVICE REPORT: FLEXVISION MONITOR WENT DARK. THE FD SYSTEM, THE X-RAY GENERATOR, AND ALL OF THE MONITORS IN THE CONTROL ROOM REMAINED OPERATIONAL. WHAT ACTIONS WERE TAKEN TO REPAIR THE EQUIPMENT? REPLACED THE DCPS POWER SUPPLY IN THE B-CABINET. THE CUSTOMER WAS ADVISED THAT IF THE PROBLEM HAPPENS AGAIN, TO PLEASE NOTE THE COLOR OF THE LED IN THE BOTTOM RIGHT CORNER OF THE FLEXVISION TO HELP WITH DIAGNOSTICS. TESTED THE SYSTEM AND THE SYSTEM CHECKED OK." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }