{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 11 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "2126677-2009-00010", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20090226", "manufacturer_address_2": "", "pma_pmn_number": "K051967", "date_of_event": "20090127", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20090819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090226", "brand_name": "DEFINIUM 8000", "generic_name": "KPR/IZF/MQB", "manufacturer_d_name": "GE MEDICAL SYSTEMS, LLC", "manufacturer_d_address_1": "3000 N GRANDVIEW BLVD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "WAUKESHA", "manufacturer_d_state": "WI", "manufacturer_d_zip_code": "53188", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "53188", "device_operator": "HEALTH PROFESSIONAL", "model_number": "5131070", "catalog_number": "NA", "lot_number": "NA", "other_id_number": "NA", "device_availability": "Yes", "device_report_product_code": "KPR", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ], "product_problems": [ "Device Slipped", "Device Operates Differently Than Expected", "Unintended Movement" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20090226", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20090127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1334719", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20090127", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "1081845", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THE TABLE LOCKS DID NOT ACTUATE WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). ACCORDING TO THE SITE, THE ISSUE WAS INTERMITTENT. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL." }, { "mdr_text_key": "8175834", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE GE FIELD ENGINEER (FE) FOUND THAT THE RIGHTMOST TABLETOP-LOCK PEDAL LOCATED ON THE FRONT PEDAL ASSEMBLY WAS STICKING INTERMITTENTLY. AFTER FURTHER INSPECTION, THE FE FOUND THAT THE PIVOTS IN THE PEDAL ASSEMBLY WERE WORN FOR USE, WHICH PREVENTED THE FLAGS FROM PROPERLY SEATING ITSELF WITH THE OPTO-COUPLER. THIS RESULTED IN THE REPORTED FLOAT. 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