{ "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": 19 } }, "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": "9610816-2022-00295", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220524", "manufacturer_address_2": "", "pma_pmn_number": "K140535", "date_of_event": "20220503", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "02141", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "6172455900", "noe_summarized": "1", "manufacturer_contact_l_name": "SAMMARCO", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "71034", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "617", "date_added": "20220525", "manufacturer_contact_f_name": "DEREK", "device_date_of_manufacturer": "20110916", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2202946", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220524", "brand_name": "AVALON FM20 FETAL MONITOR", "generic_name": "AVALON FM20 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": "M2702A", "catalog_number": "M2702A", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HGM", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00884838000407", "udi_public": "00884838000407", "openfda": { "device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2" } } ], "product_problems": [ "Image Display Error/Artifact", "Image Display Error/Artifact" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/16/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250805", "health_professional": "Y", "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": "20220524", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "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": "14492007", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220503", "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": "292606892", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION." }, { "mdr_text_key": "292606893", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CUSTOMER REPORTED THAT THE AVALON FM20 FETAL MONITOR FREEZES AND STOPS PRINTING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED." }, { "mdr_text_key": "330862448", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE BIOMED REPORTED THAT THE AVALON FM20 FETAL MONITOR KEEPS FREEZING AND IT STOPS PRINTING, THE DISPLAY GOES OUT, BUT THE UNIT DOES NOT SHUT OFF. WHEN THE DISPLAY COMES BACK ON IT IS ON THE PATIENT SCREEN (STALE DATA) NOT THE START UP SCREEN. THE DEVICE WAS SENT IN TO BENCH REPAIR FOR FURTHER EVALUATION. DURING BENCH REPAIR IT WAS FOUND THAT THE MAIN BOARD WAS FAULTY AND NEEDED TO BE REPLACED TO RESOLVE THE REPORTED ISSUE. THE PROBLEM WAS RESOLVED BY REPLACING THE MIN BOARD. THE REPAIRED DEVICE WAS RETURNED BACK TO THE CUSTOMER'S FACILITY." } ], "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": "09/02/2022" } ] }