{ "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": 3110 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "Death", "report_number": "3003829651-2008-00008", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080221", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20071225", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080227", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080221", "brand_name": "LIFESYNC ECG SYSTEM", "generic_name": "WIRELESS ECG SYSTEM", "manufacturer_d_name": "LIFESYNC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "FORT LAUDERDALE", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "0", "model_number": "NOT PROVIDED", "catalog_number": "NOT PROVIDED", "lot_number": "NOT PROVIDED", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DRT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2300", "device_class": "2" } } ], "product_problems": [ "Lead(s), breakage of", "Monitor failure" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20080221", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20080214", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1001563", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080122", "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": "20897443", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A LIFESYNC CORPORATION SALES REPRESENTATIVE WAS RECORDING FEEDBACK OBTAINED DURING A MEETING WITH A CUSTOMER. THE CUSTOMER INDICATED TO THE LIFESYNC REPRESENTATIVE THAT THEY WERE ATTEMPTING TO RESUSCITATE A PATIENT THAT WAS IN CARDIAC ARREST, WHILE PERFORMING CPR, THE LEADWEAR BROKE. THE CUSTOMER INDICATED THAT THE BREAK IN THE LEADWEAR MADE IT DIFFICULT TO MONITOR THE PATIENT DURING THE CARDIAC ARREST. MONITOR OF THE PATIENT RESUMED WHEN DEFIBRILLATOR PADS WERE PLACED. BROKEN LEADWEAR DURING RESUSCITATION HAS THE POTENTIAL TO LEAD TO A DELAY IN TREATMENT DURING AN EMERGENCY PROCEDURE." }, { "mdr_text_key": "21191289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER INDICATED THAT THE PATIENT DID NOT SURVIVE THE CARDIAC ARREST. ADDITIONAL CLARIFICATION / INVESTIGATION PERFORMED ON BEHALF OF LIFESYNC CORPORATION WITH NURSES THAT WERE ON SITE AT THE TIME OF THE INCIDENT INDICATED THAT THE LEADWEAR BROKE DURING CHEST COMPRESSIONS, THE PATIENT WAS GRAVELY ILL AT THE TIME OF THE INCIDENT, AND THE OUTCOME OF RESUSCITATION WAS NOT IMPACTED IN ANY WAY BY THE LEADWEAR BREAK. IN THIS CASE, A DEVICE FAILURE OCCURRED, BUT WAS NOT RELATED TO THE OUTCOME OF TREATMENT TO THE PATIENT. DEVICE FAILURE WAS NOT RELATED TO THE DEATH OF THE PATIENT." } ], "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": "" } ] }