{
  "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,
      "limit": 1,
      "total": 31
    }
  },
  "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": "9615102-2020-00115",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20201114",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K141936",
      "date_of_event": "20201013",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "003",
      "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": "FR",
      "manufacturer_contact_area_code": "",
      "date_added": "20201114",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1306443",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20201114",
          "brand_name": "MICROLAB",
          "generic_name": "SPIROMETER, DIAGNOSTIC",
          "manufacturer_d_name": "VYAIRE MEDICAL",
          "manufacturer_d_address_1": "22745 SAVI RANCH PKWY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "YORBA LINDA",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92887",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92887",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "FGO MLAB8 SPIROMETER",
          "catalog_number": "36-ML3500 MK8-STK",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "BZG",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "54250892905551",
          "udi_public": "(01)54250892905551",
          "openfda": {
            "registration_number": [
              "9615102"
            ],
            "fei_number": [
              "1000271197"
            ],
            "device_name": "Spirometer, Diagnostic",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.1840",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Electrical Shorting",
        "Electrical Shorting"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "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": "20201114",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20201014",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10841313",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201014",
      "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": "217701662",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4). A VYAIRE TECHNICAL SUPPORT REVIEWED THE INFORMATION GIVEN BY THE CUSTOMER AND FOUND THAT THE UNIT HAS A DEFECTIVE ELECTRICAL COMPONENT. UNIT WILL BE SENT TO VYAIRE FAILURE ANALYSIS LABORATORY FOR FURTHER EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE."
        },
        {
          "mdr_text_key": "217701663",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT IS REPORTED TO VYAIRE MEDICAL THAT THE MICROLAB SPIROMETER EXPERIENCED A BURNT PC BOARD AND A NON-FUNCTIONING LCD. THERE WAS NO PATIENT INVOLVED WITH THE REPORTED ISSUE."
        }
      ],
      "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": ""
    }
  ]
}