{ "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": 12 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "GORT", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "WI", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY H91PD92,", "manufacturer_contact_address_1": "3150 PLEASANT VIEW ROAD", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "3010611950-2022-00003", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220830", "manufacturer_address_2": "", "pma_pmn_number": "K890495", "date_of_event": "20220819", "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": "WALSH", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20220830", "manufacturer_contact_f_name": "GRÁINNE", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134293", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220830", "brand_name": "VIKING EDX INTERNATIONAL", "generic_name": "VIKING EDX INTERNATIONAL", "manufacturer_d_name": "NATUS NEUROLOGY INCOPORATED", "manufacturer_d_address_1": "3150 PLEASANT VIEW ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIDDLETON, 53562", "manufacturer_d_state": "WI", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "982A0568", "catalog_number": "982A0568", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "IKN", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Electromyograph, Diagnostic", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.1375", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/19/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250807", "health_professional": "N", "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": "20220830", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Localized Skin Lesion", "Localized Skin Lesion" ] } ], "distributor_city": "", "date_report": "20220929", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MIDDLETON, 53562", "mdr_report_key": "15319398", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220819", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "NATUS MANUFACTURING LIMITED", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "305246833", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INITIAL REPORT REF NATUS COMPLAINT#(B)(4). SERVICE TECHNICIAN SPOKE WITH THE CUSTOMER AND REQUESTED THAT THEY NO LONGER USE THE SYSTEM UNTIL A NATUS FIELD SERVICE TECHNICIAN HAS BEEN ONSITE TO TEST THE SYSTEM. PER INFORMATION RECEIVED: PATIENT INVOLVED :YES. ALLEGED INJURY: YES. ALLEGED DELAY IN TREATMENT: YES. ALLEGED ENVIRONMENTAL OR SAFETY ISSUE: YES. 25-AUGUST-2022: A REQUESTED THAT A ADVERSE EVENT QUESTIONNAIRE BE SENT TO THE CUSTOMER. FURTHER REVIEW OF INVESTIGATION DETAILS TO BE CARRIED OUT." }, { "mdr_text_key": "305246834", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "VIKING EDX INTERNATIONAL - THE CUSTOMER REPORTS THERE WAS SKIN LESIONS AFTER APPLICATION AND REQUESTED THAT THE DEVICE BE CHECKED FOR ERROR CURRENTS." }, { "mdr_text_key": "331700402", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4) A NATUS FIELD SERVICE TECHNICIAN VISITED THE CUSTOMER TO CHECK THE SYSTEM. THE SYSTEM WAS CHECKED FOR SAFETY, AND NO ISSUE WAS FOUND. CAPA TRENDING REVIEW: THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED PER (B)(4) EMG-IOM RISK ANALYSIS FILE, HAZARD ID - 10.2, SEVERITY 3 - MARGINAL, THE RISK IS CONSIDERED LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS A DEVICE HISTORY RECORD REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. INSTALL DATE: MARCH 26, 2016. \"FAILURE\" CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED." }, { "mdr_text_key": "331700403", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "VIKING EDX INTERNATIONAL - THE CUSTOMER REPORTS THERE WAS SKIN LESIONS AFTER APPLICATION AND REQUESTED THAT THE DEVICE BE CHECKED FOR ERROR CURRENTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "IDA BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/30/2022" } ] }