{
  "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,
      "limit": 1,
      "total": 5
    }
  },
  "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": "1253376",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20081201",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20081119",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "report_date": "20081201",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "",
      "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": "20081209",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20081201",
          "brand_name": "DRAGER EVITA XL",
          "generic_name": "VENTILATOR",
          "manufacturer_d_name": "DRAGER MEDICAL",
          "manufacturer_d_address_1": "3135 QUARRY ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "TELFORD",
          "manufacturer_d_state": "PA",
          "manufacturer_d_zip_code": "18969",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "18969",
          "device_operator": "INVALID DATA",
          "model_number": "EVITA XL",
          "catalog_number": "*",
          "lot_number": "*",
          "other_id_number": "*",
          "device_availability": "Device was returned to manufacturer",
          "device_report_product_code": "CBK",
          "device_age_text": "5 YR",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Ventilator, Continuous, Facility Use",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5895",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Blank screen",
        "Heat",
        "Device Emits Odor",
        "Power Conditioning Problem",
        "Replace",
        "Noise"
      ],
      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
      "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": "20081201",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "62 YR",
          "patient_sex": "",
          "patient_weight": "103",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Manual ventilation required"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20081201",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1253376",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20081201",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "1012564",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THERE WAS A POWER SURGE AND AFTER THE SURGE A LOUD HIGH PITCHED SQUEAL WAS HEARD. THE MONITOR ON THE VENTILATOR WENT BLACK AND DID NOT WORK. THE ROOM SMELLED SMOKEY, BUT NO SMOKE WAS WITNESSED. THE MONITOR WAS ALSO HOT TO TOUCH. PATIENT WAS BAGGED AND A NEW VENTILATOR WAS PLACED ON THE PATIENT.====================== MANUFACTURER RESPONSE FOR VENTILATOR, DRAGER EVITA XL======================NOTHING AS YET"
        }
      ],
      "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": ""
    }
  ]
}