{
  "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": "2026-06-30",
    "results": {
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    }
  },
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    {
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      "report_to_fda": "N",
      "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": "",
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      "type_of_report": [
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        "Followup",
        "Followup",
        "Followup"
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      "date_received": "20021113",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "BIOMEDICAL ENGINEER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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        "User facility"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20021119",
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        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
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          "date_received": "20021113",
          "brand_name": "NELLCOR N-595 PULSE OXIMETER",
          "generic_name": "PULSE OXIMETER",
          "manufacturer_d_name": "NELLCOR PURITAN BENNETT",
          "manufacturer_d_address_1": "4280 HACIENDA DR.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "PLEASANTON",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "94588",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94588",
          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "N595",
          "lot_number": "NA",
          "other_id_number": "*",
          "device_availability": "Device was returned to manufacturer",
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          "device_report_product_code": "KSZ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Test, Automated Blood Grouping And Antibody",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.9175",
            "device_class": "2"
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        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "MN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*;*;*",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20021113",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "UNKNOWN",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unknown (for use when the patient's condition is not known)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20021113",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "428029",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "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": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "278155",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "NELLCOR WAS INFORMED BY A BIOMEDICAL ENGINEER THAT THE VISUAL ALARMS WERE ACTIVE, BUT NO AUDIBLE ALARMS COULD BE HEARD FROM THE PULSE OXIMETER. THE MONITOR WAS RETURNED FOR INVESTIGATION, AND DIFFICULTY WAS ISOLATED TO THE SPEAKER. THE SPEAKER HAS BEEN RETURNED TO THE VENDOR FOR EVALUATION."
        }
      ],
      "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": "*;*;*"
    }
  ]
}