{
  "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": "2026-06-30",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "event_location": "",
      "report_to_fda": "",
      "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": "MW5013634",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20091118",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20091117",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "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": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20091130",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20091118",
          "brand_name": "PHILIPS HEARTSTART MRX ALS MONITOR",
          "generic_name": "PHILIPS MRX CARDIAC MONITOR/DEFIBRILLATOR",
          "manufacturer_d_name": "PHILIPS ELECTRONICS NORTH AMERICA",
          "manufacturer_d_address_1": "3000 MINUTEMAN RD",
          "manufacturer_d_address_2": "MS 109",
          "manufacturer_d_city": "ANDOVER",
          "manufacturer_d_state": "MA",
          "manufacturer_d_zip_code": "01810",
          "manufacturer_d_zip_code_ext": "109",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "01810 1099",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "M-3538A",
          "catalog_number": "NA",
          "lot_number": "NA",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "MKJ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Automated External Defibrillators (Non-Wearable)",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.5310",
            "device_class": "3"
          }
        }
      ],
      "product_problems": [
        "Failure to Power Up",
        "Device Displays Incorrect Message"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250822",
      "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": "20091118",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Patient Involvement"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20091118",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1544004",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "1251374",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WHILE TESTING A PHILIPS MRX CARDIAC MONITOR/DEFIBRILLATOR, MODEL #M3538A, THE CARDIAC MONITOR/DEFIBRILLATOR DEVICE WOULD NOT POWER ON. THE DEFIBRILLATOR HAD A FULLY CHARGED BATTERY, AND WHEN THE GREEN POWER ROTARY SWITCH WAS ROTATED, THE DEVICE FAILED TO POWER ON. THE ROTARY SWITCH WAS ROTATED SEVEN TIMES, WITHOUT ANY SUCCESS. THE DEVICE DISPLAY SCREEN FINALLY POWERED ON AFTER THE EIGHTH TRY. IT DISPLAYED A SERVICE MESSAGE, AND THERE WAS AN X IN THE \"READY FOR USE\" INDICATOR STATUS WINDOW AS WELL AS AN AUDIBLE CHURP. THE DEVICE WAS REMOVED FROM SERVICE AND THE MFR WAS NOTIFIED. NO PT WAS INVOLVED IN THIS DEVICE TESTING. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: TESTING OF MEDICAL DEVICE."
        }
      ],
      "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": ""
    }
  ]
}