{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "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": "",
      "event_type": "Malfunction",
      "report_number": "1051786-2020-00025",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200501",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K090785",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "FOREIGN",
        "HEALTH PROFESSIONAL",
        "U"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "BE",
      "manufacturer_contact_area_code": "",
      "date_added": "20200501",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "480110",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200501",
          "brand_name": "INVIVO CORPORATION",
          "generic_name": "PATIENT MONITOR",
          "manufacturer_d_name": "INVIVO CORPORATION",
          "manufacturer_d_address_1": "12151 RESEARCH PARKWAY",
          "manufacturer_d_address_2": "SUITE 200",
          "manufacturer_d_city": "ORLANDO",
          "manufacturer_d_state": "FL",
          "manufacturer_d_zip_code": "32826",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "32826",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "453564180091",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "MWI",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "1051786"
            ],
            "fei_number": [
              "1051786"
            ],
            "device_name": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2300",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "No Display/Image",
        "Output Problem",
        "Device Fell"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/27/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
      "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": "20200501",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Patient Involvement",
            "No Patient Involvement"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10017287",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200427",
      "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": "317332224",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H3 OTHER TEXT : THE CUSTOMER STATED THAT HE WAS ABLE TO FIX THE DEVICE ON HIS OWN AND DID NOT REQUIRE INTERVENTION FROM PHILIPS."
        },
        {
          "mdr_text_key": "200450081",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "CUSTOMER DID NOT PROVIDE SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE."
        },
        {
          "mdr_text_key": "200450082",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE CUSTOMER STATED THAT THE MONITOR FELL AND DOES NOT WORK ANYMORE. THE CUSTOMER FURTHER REPORTED THAT THE MONITOR IS NOT CRACKED, BUT THE SCREEN REMAINS BLANK AND THE DEVICE DOES NOT START. THE DEVICE WAS NOT IN USE ON A PATIENT."
        }
      ],
      "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": "06/08/2020"
    }
  ]
}