{ "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": 10 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "10400935", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200813", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200811", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200811", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "864547", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200813", "brand_name": "PHILIPS PAGEWRITER TC70", "generic_name": "ELECTROCARDIOGRAPH", "manufacturer_d_name": "PHILIPS NORTH AMERICA, LLC", "manufacturer_d_address_1": "3000 MINUTEMAN RD", "manufacturer_d_address_2": "", "manufacturer_d_city": "ANDOVER", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01810", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01810", "device_operator": "I", "model_number": "TC70", "catalog_number": "", "lot_number": "1446-0156", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "DPS", "device_age_text": "5 YR", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Electrocardiograph", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2340", "device_class": "2" } } ], "product_problems": [ "Fire", "Smoking", "Explosion" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20200813", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "20075 DA", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200811", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200813", "manufacturer_contact_city": "", "mdr_report_key": "10400935", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200811", "manufacturer_name": "", "report_source_code": "User Facility report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202704809", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN THE EARLY MORNING, EMERGENCY DEPARTMENT STAFF SMELLED FIRE SMOKE, INVESTIGATING IT LEAD THEM TO AN ECG DEVICE PLUGGED IN ONE OF THE ED BAYS. AFTER FEW MINUTES, THE DEVICE STARTED TO SPARK AND IN NO TIME IT CAUGHT ON FIRE. STAFF MOVED THE DEVICE TO OUTSIDE THE BUILDING, WHERE FLAMES WERE ALL OVER THE DEVICE. USING A FIRE EXTINGUISHER, THE STAFF EXTINGUISHED THE FIRE. YET, THE UNIT BURSTS IN FLAMES AGAIN, EXTINGUISHED AGAIN, AND THEN FIRE STARTS AGAIN. STAFF MOVED THE UNIT FURTHER AWAY FROM THE BUILDING, AND CALLED FIRE DEPARTMENT. AFTER FEW MINUTES, THE UNIT MADE A MINI EXPLOSION, SHOOTING THE BATTERIES OFF ABOUT 40 FEET AWAY IN WHAT SEEMED TO BE A BALL OF FIRE. EVENTUALLY, STAFF WERE ABLE TO EXTINGUISH THE FLAMES, KEEPING THE UNIT OUTSIDE. BIOMED DID THE INVESTIGATION ON THE UNIT, AND APPEARED THE BATTERIES ARE THE REASON OF THE FIRE AND THE EXPLOSION. BATTERIES ARE THE ORIGINAL PHILIPS BATTERIES THAT CAME WITH THE UNIT. BIOMED REMOVED ALL BATTERIES FROM ALL PHILIPS ECG UNITS IN THE HEALTH SYSTEM. PHILIPS SERVICE MANUAL DOESN'T INCLUDE ANY REQUIREMENT TO REPLACE THE BATTERIES AT ANY FREQUENCY. ATTACHED TO THIS REPORT THE BATTERY MAINTENANCE AND PERFORMANCE VERIFICATION INSTRUCTIONS FROM THE SERVICE MANUAL. MANUFACTURER RESPONSE FOR ECG, PHILIPS (PER SITE REPORTER). THEY WILL ESCALATE TO THEIR TEAMS TO CHECK." } ], "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": "" } ] }