{
  "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",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "UK",
      "manufacturer_contact_area_code": "",
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          "manufacturer_d_address_1": "1001 MURRY RIDGE LANE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MURRYSVILLE, PA",
          "manufacturer_d_state": "",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "05/07/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
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          "patient_problems": [
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            "No Consequences Or Impact To Patient"
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        }
      ],
      "distributor_city": "",
      "date_report": "20200407",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000611",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200407",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
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          "mdr_text_key": "189072753",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, \"SERVICE REQUIRED\" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUES."
        },
        {
          "mdr_text_key": "191796414",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IT WAS INITIALLY REPORTED, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, \"SERVICE REQUIRED\" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUES. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE ALSO FAILED A STEP DURING TESTING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE 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": "05/12/2020"
    }
  ]
}