{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "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": "Malfunction",
      "report_number": "8030673-2020-00095",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200330",
      "reprocessed_and_reused_flag": "Y",
      "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": [
        "FOREIGN",
        "USER FACILITY"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "CA",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "463938",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "AIRLIFE MISTY-NEB MEDICATION NEBULIZERS",
          "generic_name": "NEBULIZING SYSTEM, NON-HEATED",
          "manufacturer_d_name": "VYAIRE MEDICAL",
          "manufacturer_d_address_1": "26125 N. RIVERWOODS BLVD.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "METTAWA, IL",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "AIRLIFE MISTY-NEB MEDICATION NEBULIZERS",
          "catalog_number": "002438",
          "lot_number": "0004103399",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20200427",
          "device_report_product_code": "CAF",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "10190752114869",
          "udi_public": "(01)10190752114869(10)0004103399",
          "openfda": {
            "registration_number": [
              "8030673"
            ],
            "fei_number": [
              "3004213967"
            ],
            "device_name": "Nebulizer (Direct Patient Interface)",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5630",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Defective Component",
        "Defective Component"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "08/21/2020",
      "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": "20200427",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200330",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10001964",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200330",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "315661511",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "RESULT OF INVESTIGATION: REVIEW OF DEVICE HISTORY RECORD OF THE LOT NUMBER REVEALED NO ANOMALIES, AND A SAMPLE HAD BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. UNFORTUNATELY, THAT SAMPLE WAS DISCARDED BY MISTAKE. HOWEVER, TECHNICAL TEAM INDICATED THAT CAPA-000000567 HAS BEEN INITIATED BASED ON A SIMILAR PROBLEM, AND THE MANUFACTURING DATE OF THE PRODUCT REPORTED ON THIS COMPLAINT IS COVERED BY THAT CAPA. THEREFORE, TECHNICAL TEAM IS CONFIRMING THE REPORTED FAILURE."
        },
        {
          "mdr_text_key": "200443600",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "NO SAMPLES WERE RETURNED AS OF NOW. A SECOND NEBULIZER WAS OBTAINED AND SET UP. MEDICATION TRANSFERRED AND MISTED APPROPRIATELY ON THE SECOND NEBULIZER. THE CUSTOMER CONFIRMED THAT NO HARM OCCURRED TO THE PATIENT. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT."
        },
        {
          "mdr_text_key": "200443601",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE CUSTOMER REPORTED THAT THE AIRLIFE MISTY MAX 10 NEBULIZER WOULD NOT MIST. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT."
        }
      ],
      "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": "09/05/2020"
    }
  ]
}