{
  "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": "2026-05-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 494
    }
  },
  "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": "3030677-2008-00001",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20080514",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K040904",
      "date_of_event": "20070421",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20080408",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Literature"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20080523",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080514",
          "brand_name": "PHILIPS HEARTSTART HOME DEFIBRILLATOR",
          "generic_name": "AED, DEFIBRILLATOR",
          "manufacturer_d_name": "PHILIPS MEDICAL SYSTEMS",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SEATTLE",
          "manufacturer_d_state": "WA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "M5068",
          "catalog_number": "M5068A",
          "lot_number": "",
          "other_id_number": "NA",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20080330",
          "device_report_product_code": "MKJ",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Automated External Defibrillators (Non-Wearable)",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.5310",
            "device_class": "3"
          }
        }
      ],
      "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": "20080514",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Death"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        }
      ],
      "distributor_city": "",
      "date_report": "20080514",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1047487",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080415",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Other"
      ],
      "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": "848206",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE DEVICE'S ON/OFF BUTTON WAS PUSHED AND THE DEVICE TURNED OFF, WHEN THE RHYTHM WAS SHOCKABLE."
        },
        {
          "mdr_text_key": "8059699",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "METHOD: A REVIEW OF THE DEVICE'S INTERNAL MEMORY SHOWED THE DEVICE WAS TURNED ON AND OFF MULTIPLE TIMES PRIOR TO THE LAST TIME. CONCLUSIONS: THIS EVENT IS BEING FILED SINCE IT CANNOT BE CONCLUSIVELY BE DETERMINED IF DELIVERING A SHOCK WOULD HAVE AFFECTED THE OUTCOME. THE USER OF THE DEVICE WAS THE VICTIM'S SON AND WAS NOT TRAINED ON THE DEVICE. THERE ARE MANY REDUNDANT FEATURES TO INDICATE PRESSING THE SHOCK BUTTON, INCLUDING VOICE INSTRUCTIONS AND FLASHING LED UNDERNEATH THE SHOCK BUTTON AND THE LABELING INTENDED TO BE STORED WITH THE DEVICE. THE LABELING ALSO ENCOURAGES ANYONE THAT MAY USE THE DEVICE RECEIVE TRAINING. EMERGENCY MEDICAL SERVICES WERE CALLED, ARRIVED 7 MINUTES LATER, BUT THE DEFIBRILLATOR ATTACHED BY EMS DID NOT RESULT IN A SHOCK ADVISORY. TYPICAL ADVANCED LIFE SAVING MEASURES WERE TAKEN. IT IS REPORTED THAT CPR WAS PERFORMED PRIOR TO EMS ARRIVAL. THE EVENT OCCURRED IN NEW ZEALAND."
        }
      ],
      "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": ""
    }
  ]
}