{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 72 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "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": "Injury", "report_number": "3009715978-2020-00002", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200522", "manufacturer_address_2": "", "pma_pmn_number": "K191406", "date_of_event": "20200422", "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": [ "CONSUMER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200522", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "546116", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200522", "brand_name": "KARDIAMOBILE", "generic_name": "MOBILE ELECTROCARDIOGRAM", "manufacturer_d_name": "ALIVECOR, INC.", "manufacturer_d_address_1": "444 CASTRO STREET", "manufacturer_d_address_2": "SUITE 600", "manufacturer_d_city": "MOUNTAIN VIEW, CA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "LAY USER/PATIENT", "model_number": "AC-009", "catalog_number": "AC-009", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200430", "device_report_product_code": "DXH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "B210AC0090", "udi_public": "+B210AC0090", "openfda": { "registration_number": [ "3009715978" ], "fei_number": [ "3009715978" ], "device_name": "Transmitters And Receivers, Electrocardiograph, Telephone", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2920", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20200522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Chest Pain", "Myocardial Infarction", "Neck Pain", "Chest Pain", "Myocardial Infarction", "Neck Pain" ] } ], "distributor_city": "", "date_report": "20200521", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10084224", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200425", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194330373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ALIVECOR RECEIVED A COMPLAINT FROM USER/PATIENT WHERE IT APPEARS THAT THE USER WHILE EXPERIENCING A HEART ATTACK RECORDED AN ECG AND RECEIVED DEVICE ALGORITHM ANALYSIS OF \"NORMAL SINUS RHYTHM\". THE PATIENT DID NOT DELAY SEEKING MEDICAL ATTENTION DUE TO THE KARDIAMOBILE RESULT AND RUSHED TO THE EMERGENCY ROOM. ALIVECOR'S KARDIAMOBILE IS A LEAD-I MOBILE ECG DEVICE THAT IS NOT INTENDED TO DETECT HEART ATTACKS. THE DEVICE LABELING SPECIFIES THAT THE DEVICE DOES NOT DETECT HEART ATTACKS. FOR INVESTIGATION, THE ECG FROM THE USER WAS SENT TO A CARDIOLOGIST FOR REVIEW AND ANALYSIS. THE CARDIOLOGIST CONCURRED WITH KARDIAMOBILE DETERMINATION AND CONFIRMED THAT THE ECG FROM THE USER WAS INDEED IN NORMAL SINUS RHYTHM. BASED ON THE INVESTIGATION RESULTS, ALIVECOR CONCLUDED THAT THE DEVICE HAD NOT MALFUNCTIONED BECAUSE IT PERFORMED AS INTENDED, DID NOT CAUSE OR CONTRIBUTE TO THE HEART ATTACK, AND THE INCIDENT WAS A RESULT OF USER ERROR." }, { "mdr_text_key": "194330374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT CONTACTED ALIVECOR ON (B)(6) 2020 STATING THAT SHE USED KARDIAMOBILE TO TAKE EKG AND RECEIVED NORMAL SINUS RHYTHM DETERMINATION WHILE EXPERIENCING A HEART ATTACK. THE SPECIFIC COMMENTS FROM THE PATIENT NOTES THAT \"ON (B)(6), I STARTED HAVING CHEST PAIN, LEFT ARM/SHOULDER PRESSURE/PAIN, NECK AND JAW PAIN. I HAD NOT USED THE KARDIA UNIT IN A WHILE AND HAD TO UPDATE THE APP ON MY PHONE. AFTER MORE THAN FEW ATTEMPTS I GOT A READING THAT SAID NORMAL EKG.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }