{
  "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": "I",
      "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": "3019216-2020-00110",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20201112",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K132304",
      "date_of_event": "20201019",
      "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": [
        "HEALTH PROFESSIONAL"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20201019",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20201112",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1296545",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20201112",
          "brand_name": "EPIQ 7",
          "generic_name": "SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC",
          "manufacturer_d_name": "PHILIPS ULTRASOUND",
          "manufacturer_d_address_1": "22100 BOTHELL EVERETT HIGHWAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "BOTHELL",
          "manufacturer_d_state": "WA",
          "manufacturer_d_zip_code": "98021",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "98021",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM",
          "catalog_number": "795201",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "IYN",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00884838097872",
          "udi_public": "00884838097872",
          "openfda": {
            "registration_number": [
              "3019216"
            ],
            "fei_number": [
              "3019216"
            ],
            "device_name": "System, Imaging, Pulsed Doppler, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1550",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Unintended System Motion",
        "Unintended System Motion"
      ],
      "reporter_state_code": "NY",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250805",
      "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": "20201112",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10833273",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201019",
      "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": "216146001",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE PHILIPS FIELD SERVICE ENGINEER PERFORMED A SYSTEM INSPECTION AND DETERMINED THAT THE CONTROL PANEL ARM¿S LOCKING PIN COLLAR HAD RISEN OUT OF PLACE PREVENTING A PROPER LOCK. THE SERVICE ENGINEER WAS ABLE TO RESEAT THE COLLAR INTO THE CORRECT POSITION TO RESOLVE THE ISSUE. AS THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO PART RETURN ANTICIPATED, NO FURTHER FAILURE ANALYSIS CAN BE PERFORMED."
        },
        {
          "mdr_text_key": "216146002",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR EPIQ ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK PROPERLY WHILE IN TRANSIT. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF 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": ""
    }
  ]
}