{
  "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,
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "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": "Injury",
      "report_number": "MW5096202",
      "type_of_report": [
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      "product_problem_flag": "Y",
      "date_received": "20200821",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200608",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20200824",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "904607",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200821",
          "brand_name": "MINDRAY A5 ADVANTAGE / ANESTHESIA DELIVERY UNIT",
          "generic_name": "GAS-MACHINE, ANESTHESIA",
          "manufacturer_d_name": "MINDRAY DS USA, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "BSZ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Gas-Machine, Anesthesia",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5160",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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        "Therapeutic or Diagnostic Output Failure"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "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": "20200821",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "33 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200820",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10442748",
      "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": "204248921",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "MINDRAY ANESTHESIA MACHINE WAS REPAIRED ON (B)(6) 2020 AND CLEARED FOR USE. MACHINE PASSED STARTUP TEST AM OF (B)(6) 2020, DURING CASE BREATHING ASSEMBLY NOT WORKING CORRECTLY AND ANESTHESIA PROVIDER HAD TO PROVIDE MANUAL VENTILATION. BIOMEDICAL ENGINEERING DEPARTMENT CALLED IMMEDIATELY FOLLOWING CASE AND IT WAS DETERMINED THAT THERE WAS A DIFFERENT ISSUE, UNRELATED TO THE REPAIR THAT WAS WRONG WITH THE MACHINE. MACHINE OUT OF SERVICE AND REPLACEMENT PART ON ORDER. BIOMEDICAL OUR BIOMEDICAL ENGINEERS WORKED WITH MINDRAY TO REPAIR. THEY FOUND THAT THE LEAK WAS RELATED TO THE TUBING BETWEEN THE MAIN UNIT AND THE BREATHING SECTION. THIS IS REPLACED AS PART OF THE THREE YEAR PREVENTATIVE MAINTENANCE (PM) AND ALL OF OUR UNITS HAD THE TUBE REPLACED. WE ARE REPORTING THIS TO ASSIST OTHERS THAT MAY NOT BE FOLLOWING THE PM SCHEDULE. FDA SAFETY REPORT ID# (B)(4)."
        }
      ],
      "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": ""
    }
  ]
}