{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 100681 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "3004754211-2020-27207", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K133580", "date_of_event": "20200415", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "BR", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464043", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "ARTIS ONE", "generic_name": "INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM", "manufacturer_d_name": "SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.", "manufacturer_d_address_1": "GAOXIN C AVE.", "manufacturer_d_address_2": "2ND, HI-TECH INDUSTRIAL PARK", "manufacturer_d_city": "SHENZHEN, CHINA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "51805", "manufacturer_d_zip_code_ext": "7", "manufacturer_d_country": "CH", "manufacturer_d_postal_code": "518057", "device_operator": "HEALTH PROFESSIONAL", "model_number": "10848600", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "OWB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3004754211" ], "fei_number": [ "3004754211" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/22/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "69 YR", "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": "20200417", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000478", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200417", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair", "Inspection" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197355961", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION." }, { "mdr_text_key": "197355962", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING A NEURO EMBOLIZATION PROCEDURE IN A PATIENT, THE EXAMINATION ROOM MONITOR TURNED BLACK AND THE DOCTOR COULDN'T FINISH THE PROCEDURE ACCORDINGLY. THE PATIENT WAS SENT TO THE ICU AND THE PROCEDURE WAS COMPLETED AFTER THE SYSTEM WAS REPAIRED. AT THIS TIME WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT." }, { "mdr_text_key": "317859406", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE ERROR. THE INVESTIGATION SHOWED THAT THE CAUSE OF THE ERROR IS DUE TO THE HARDWARE QUALITY OF THE DIGITAL PORT (DP) TRANSCEIVER, WHICH CONNECTS THE IMAGE PC AND ER MONITOR. ACCORDINGLY A SOLUTION IS ONGOING FOR DEVELOPMENT. A CORRECTION WILL BE INITIATED IN 2020. THE CORRECTION WILL INCLUDE REPLACEMENT OF THE DP TRANSCEIVER HARDWARE. THE FACILITY THAT INITIALLY REPORTED THE ISSUE HAS HAD THE DP TRANSCEIVER REPLACED AND THE SYSTEM IS OPERATING ACCORDING TO SPECIFICATIONS." } ], "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": "06/22/2020" } ] }