{
  "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": "2026-10-13",
    "results": {
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "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": "2031172-2014-00187",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20140912",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K092838",
      "date_of_event": "20140811",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "NOT APPLICABLE",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Distributor"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20141020",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "565333",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20140912",
          "brand_name": "RAD-8 HORIZONTAL MS-2000",
          "generic_name": "OXIMETER",
          "manufacturer_d_name": "MASIMO CORPORATION",
          "manufacturer_d_address_1": "40 AND 50 PARKER",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "IRVINE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92618",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92618",
          "device_operator": "OTHER",
          "model_number": "22042",
          "catalog_number": "9190",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20140818",
          "device_report_product_code": "DQA",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Oximeter",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2700",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Failure To Run On AC/DC"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "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": "20140912",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20140815",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "4177414",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20140815",
      "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": "21846969",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE RAD-8 DOES NOT REMAIN POWERED ON AFTER AC POWER IS REMOVED. THE RAD-8 DOES NOT WORK ON BATTERY. ADD'L INFO WAS RECEIVED THAT INDICATED THE UNIT DID NOT STAY CHARGED. ALSO, THERE WERE NO AUDIBLE ALARM OR ERROR MESSAGES OBSERVED. NO PT INCIDENT REPORTED."
        },
        {
          "mdr_text_key": "22145840",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE RETURNED DEVICE WAS EVALUATED, THE REPORTED ISSUE OF THE UNIT SHUTTING DOWN WHEN THE AC POWER WAS DISCONNECTED BY THE CUSTOMER WAS DUPLICATED. THE BATTERY WAS FOUND TO BE DEFECTIVE. THE UNIT WAS ABLE TO CHARGER A KNOWN GOOD BATTERY TO FULL CHARGE AND PERFORMED AS INTENDED. NO PT INCIDENT REPORTED. A SERVICE HISTORY REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER 3 YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT."
        }
      ],
      "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": ""
    }
  ]
}