{
  "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": "MS.",
      "manufacturer_contact_state": "WA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "BOTHELL",
      "manufacturer_contact_address_1": "22100 BOTHELL EVERETT HIGHWAY",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "3019216-2025-000077",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20250408",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K132304",
      "date_of_event": "20220921",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "98021",
      "reporter_occupation_code": "BIOMEDICAL ENGINEER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "RAMIREZ",
      "source_type": [
        "Foreign",
        "Health Professional"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "98021",
      "manufacturer_g1_state": "WA",
      "reporter_country_code": "AS",
      "manufacturer_contact_area_code": "",
      "date_added": "20250408",
      "manufacturer_contact_f_name": "ROXANNE",
      "device_date_of_manufacturer": "20140723",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "730750",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20250408",
          "brand_name": "EPIQ 7",
          "generic_name": "SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC",
          "manufacturer_d_name": "PHILIPS ULTRASOUND, INC",
          "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": "",
          "catalog_number": "795200",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "IYN",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "00884838047693",
          "udi_public": "(01)00884838047693",
          "openfda": {
            "device_name": "System, Imaging, Pulsed Doppler, Ultrasonic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1550",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Material Integrity Problem",
        "Material Integrity Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "07/07/2025",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250911",
      "health_professional": "Y",
      "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": "20250408",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250714",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "BOTHELL",
      "mdr_report_key": "21800704",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20220921",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "98021",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "PHILIPS ULTRASOUND, INC",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "367880247",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED A HOLE WAS FOUND IN THE C10-3V TRANSDUCER LENS AND IT FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED."
        },
        {
          "mdr_text_key": "379859683",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "H11: THE INITIAL REPORT INADVERTENTLY REPORTED AN INCORRECT DATE RECEIVED BY MFG (G3) AND SHOULD HAVE BEEN 21MAR2025. A THOROUGH INVESTIGATION WAS UNABLE TO BE PERFORMED TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. THE TRANSDUCER WAS NO LONGER AVAILABLE; THEREFORE, NO REPAIR OR EVALUATION DATA COULD BE OBTAINED. NO ADDITIONAL INVESTIGATION IS POSSIBLE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "22100 BOTHELL EVERETT HIGHWAY",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "98021",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "07/14/2025"
    }
  ]
}