{ "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": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "ENSCHEDE", "manufacturer_contact_address_1": "5420 FELTL RD", "manufacturer_contact_pcity": "21826436", "event_type": "Injury", "report_number": "3017448360-2023-00012", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230227", "manufacturer_address_2": "", "pma_pmn_number": "K121014", "date_of_event": "20220915", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55343", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "2182643600", "noe_summarized": "1", "manufacturer_contact_l_name": "MOORE", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "7521 PV", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "218", "date_added": "20230227", "manufacturer_contact_f_name": "MEGHAN", "device_date_of_manufacturer": "20211117", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "398324", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230227", "brand_name": "SOLAR GI HRM H2O 24P TROLLEY SYSTEM", "generic_name": "SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)", "manufacturer_d_name": "MEDICAL MEASUREMENT SYSTEMS B.V.", "manufacturer_d_address_1": "COLOSSEUM 25", "manufacturer_d_address_2": "", "manufacturer_d_city": "ENSCHEDE", "manufacturer_d_state": "", "manufacturer_d_zip_code": "7521", "manufacturer_d_zip_code_ext": "PV", "manufacturer_d_country": "NL", "manufacturer_d_postal_code": "7521 PV", "device_operator": "HEALTH PROFESSIONAL", "model_number": "G3-8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "FFX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "08717775955061", "udi_public": "08717775955061", "openfda": { "device_name": "System, Gastrointestinal Motility (Electrical)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1725", "device_class": "2" } } ], "product_problems": [ "Excess Flow or Over-Infusion", "Excess Flow or Over-Infusion" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/27/2023", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250803", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "PV", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "2182", "patient": [ { "patient_sequence_number": "1", "date_received": "20230227", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "6 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Convulsion/Seizure", "Convulsion/Seizure" ] } ], "distributor_city": "", "date_report": "20230605", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "NL", "manufacturer_contact_city": "MINNETONKA", "mdr_report_key": "16448312", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230127", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair" ], "manufacturer_g1_zip_code": "7521", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL MEASUREMENT SYSTEMS B.V.", "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": "334994760", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PART WAS RECEIVED AT OUR FACILITIES AND SENT TO OUR CONTRACTED MANUFACTURER: DEMCON. THE INVESTIGATION DESCRIBED BELOW WAS CARRIED OUT BY DEMCON: REPAIR// MPP PLUS // SN: (B)(6); (MAIN UNIT: (B)96)) // PUMP HAS NEGATIVE PRESSURE DESCRIPTION COMPLAINT CUSTOMER : PUMP HAS NEGATIVE PRESSURE INVESTIGATION: THE PRESSURE FOR THE WATER CONTAINER IS SHOWING -490 MBAR. THERE IS DIRT IN THE TUBING TO THE PRESSURE SENSOR, SEE PICTURE (ATTACHED). CANNOT SEE IF THE VALVES ARE AFFECTED BY LIQUID. ZEROED THE PRESSURE SENSOR AND THE OUTGOING PRESSURE IS NOW EQUAL TO THE DISPLAYED PRESSURE. POSSIBLE CAUSE OF THE PROBLEM: DUST, LIQUID. PRODUCTION YEAR: 2021-11-17. DESCRIPTION REPAIR: HAVE TO REPLACE A FEW TUBES IN THE UNIT. THEREFORE, WE CONCLUDE THAT THE ERROR WAS CAUSED BY LIQUID OR DIRT INGRESS INTO THE PRESSURE SENSOR TUBING." }, { "mdr_text_key": "310322380", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE WILL BE RETURNED TO MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. AN INVESTIGATION IS PENDING." }, { "mdr_text_key": "310322381", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THERE WAS A PATIENT IMPACT (WATER INTOXICATION & SEIZURE) AND THERE IS A FORMAL REVIEW PROCESS BEING CONDUCTED BY THE HOSPITAL. STUDY COMMENCED AT 13:40 ON (B)(6) 2022. THEY HAD A 6 YEAR-OLD FEMALE PATIENT WHO HAD A DROP IN THEIR SODIUM LEVELS FROM 138 MMOL/L (MEASURED PRIOR TO STUDY) TO 125MMOL/L (APPROX. 08:00 THE FOLLOWING MORNING). ACCORDING TO THE REPORT FROM THE DOCTOR, THE PATIENT DEVELOPED A SEIZURE FROM IATROGENIC HYPONATREMIA - WATER INTOXICATION. THE REMAINDER OF THE TEST WAS THEN ABORTED IMMEDIATELY AFTERWARDS (08:45 THE FOLLOWING MORNING). OUR CUSTOMER HAS INDICATED THAT THERE WERE NO LONG TERM EFFECTS TO THE PATIENT THAT THEY ARE AWARE OF, HOWEVER THE INCIDENT IS UNDER REVIEW IN THE HOSPITAL AND A FORMAL INCIDENT REPORT IS BEING PREPARED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "COLOSSEUM 25", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55343", "manufacturer_contact_exchange": "218", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/06/2023" } ] }