{
  "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": "2026-07-07",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "pma_pmn_number": "",
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      "exemption_number": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
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        {
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          "implant_flag": "",
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          "generic_name": "HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)",
          "manufacturer_d_name": "VAPOTHERM, INC.",
          "manufacturer_d_address_1": "100 DOMAIN DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "EXETER",
          "manufacturer_d_state": "NH",
          "manufacturer_d_zip_code": "03833",
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          "manufacturer_d_country": "US",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Humidifier, Respiratory Gas, (Direct Patient Interface)",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5450",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "FL",
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      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250801",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "patient_sequence_number": "1",
          "date_received": "20200427",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "0 DA",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
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            "Low Oxygen Saturation",
            "Increased Respiratory Rate"
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        }
      ],
      "distributor_city": "",
      "date_report": "20200421",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20200427",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000396",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20200421",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "189003436",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "BABY'S SPO2 KEPT DROPPING ON THE MONITOR. WHEN GOING TO ASSESS BABY, BABY WAS CALM AND BREATHING FAST. VAPOTHERM KEPT SHOWING THAT THERE WAS A KINK IN THE CIRCUIT. WHEN RESPIRATORY THERAPIST WENT TO GO ASSESS THE TUBE FROM PATIENT TO MACHINE THERE WAS NO KINK. THIS DEVICE HAS BEEN RETIRED, IT WAS USED AS A TRADE-IN FOR A NEW DEVICE."
        }
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}