{ "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": 45 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "B1-3/D6", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "MA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "BOBLINGEN", "manufacturer_contact_address_1": "222 JACOBS ST", "manufacturer_contact_pcity": "61724559", "event_type": "Malfunction", "report_number": "9610816-2022-00036", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220122", "manufacturer_address_2": "", "pma_pmn_number": "K140535", "date_of_event": "20211230", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "02141", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "6172455900", "noe_summarized": "1", "manufacturer_contact_l_name": "SAMMARCO", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "71034", "manufacturer_g1_state": "", "reporter_country_code": "FI", "manufacturer_contact_area_code": "617", "date_added": "20220122", "manufacturer_contact_f_name": "DEREK", "device_date_of_manufacturer": "20191017", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1949023", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220122", "brand_name": "AVALON FM30 FETAL MONITOR", "generic_name": "AVALON FM30 FETAL MONITOR", "manufacturer_d_name": "PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH", "manufacturer_d_address_1": "HEWLETT-PACKARD-STR. 2,", "manufacturer_d_address_2": "B1-3/D6", "manufacturer_d_city": "BOBLINGEN", "manufacturer_d_state": "", "manufacturer_d_zip_code": "71034", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "71034", "device_operator": "HEALTH PROFESSIONAL", "model_number": "M2703A", "catalog_number": "M2703A", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HGM", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00884838000414", "udi_public": "00884838000414", "openfda": { "device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2", "registration_number": [ "9610816" ], "fei_number": [ "3002807167" ] } } ], "product_problems": [ "Incorrect Measurement", "Incorrect Measurement" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/17/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250818", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6172", "patient": [ { "patient_sequence_number": "1", "date_received": "20220122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "GM", "manufacturer_contact_city": "CAMBRIDGE", "mdr_report_key": "13329171", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220104", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "71034", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH", "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": "285016343", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE." }, { "mdr_text_key": "285016344", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE: \"THE PATIENT UNDERWENT INTERNAL HEART RATE MONITORING, I.E., SCALP. THE CTG DRAWN BY SCALP WAS A VAGUE, ACCENTUATED VARIATION THROUGHOUT. BASELINE COULD NOT BE DETERMINED AND WHAT THE FETAL HEART RATE ACTUALLY WAS. CTG WOULD HAVE AGREED THAT THE FETUS WOULD HAVE EXTRA BEATS. SCALP WAS THEREFORE CHANGED 3 TIMES BECAUSE NO ADDITIONAL PUNCHES WERE HEARD WITH THE EXTERNAL REGISTRATION. ALL WIRES WERE ALSO REPLACED SEVERAL TIMES. THE FETAL HEART RATE WAS CONFIRMED BY ULTRASOUND AND NO ADDITIONAL BEATS WERE OBSERVED. IT WAS THEREFORE A TECHNICAL MALFUNCTION THAT COULD NOT BE RESOLVED. WITH EXTERNAL REGISTRATION, CTG WAS NORMAL. HOWEVER, THIS METHOD OF REGISTRATION WAS PROBLEMATIC BECAUSE IT SOMETIMES REGISTERS THE MOTHER¿S HEART RATE.\" THE DEVICE WAS IN USE AT TIME OF EVENT, IT IS UNKNOW IF PATIENT HARM WAS REPORTED." }, { "mdr_text_key": "330860779", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT: THE PATIENT UNDERWENT INTERNAL HEART RATE MONITORING, I.E., SCALP. THE CTG DRAWN BY SCALP WAS A VAGUE, ACCENTUATED VARIATION THROUGHOUT. BASELINE COULD NOT BE DETERMINED AND WHAT THE FETAL HEART RATE ACTUALLY WAS. CTG WOULD HAVE AGREED THAT THE FETUS WOULD HAVE EXTRA BEATS. SCALP WAS THEREFORE CHANGED 3 TIMES BECAUSE NO ADDITIONAL PUNCHES WERE HEARD WITH THE EXTERNAL REGISTRATION. ALL WIRES WERE ALSO REPLACED SEVERAL TIMES. THE FETAL HEART RATE WAS CONFIRMED BY ULTRASOUND AND NO ADDITIONAL BEATS WERE OBSERVED. IT WAS THEREFORE A TECHNICAL MALFUNCTION THAT COULD NOT BE RESOLVED. WITH EXTERNAL REGISTRATION, CTG WAS NORMAL. THE DEVICE WAS IN USE AT TIME OF EVENT, AND NO ADVERSE EVENT WAS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "HEWLETT-PACKARD-STR. 2,", "distributor_zip_code": "", "manufacturer_contact_postal_code": "02141", "manufacturer_contact_exchange": "617", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/11/2022" } ] }