{
  "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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      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "MW5017670",
      "type_of_report": [
        "Initial submission"
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      "product_problem_flag": "Y",
      "date_received": "20101004",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
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      "reporter_occupation_code": "RISK MANAGER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20101102",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20101004",
          "brand_name": "PHILIPS IE33 ULTRASOUND MACHINE",
          "generic_name": "PHILIPS IE33 ULTRASOUND MACHINE",
          "manufacturer_d_name": "PHILIPS MEDICAL SYSTEMS N.A.",
          "manufacturer_d_address_1": "22100 BOTHELL EVERETT HIGHWAY",
          "manufacturer_d_address_2": "P.O. BOX 3003",
          "manufacturer_d_city": "BOTHELL",
          "manufacturer_d_state": "WA",
          "manufacturer_d_zip_code": "98041",
          "manufacturer_d_zip_code_ext": "300",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "98041 3003",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "02XTC1 AS WELL AS 8",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "ITX",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Transducer, Ultrasonic, Diagnostic",
            "medical_specialty_description": "Radiology",
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            "device_class": "2"
          }
        }
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      "product_problems": [
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      "reporter_state_code": "SD",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250725",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20101004",
          "sequence_number_treatment": [
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          ],
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            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20101004",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1861294",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "1698626",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ISSUE/PROBLEM WITH MACHINE: BUTTONS ON THE TOUCH PANEL WORK INTERMITTENTLY. SPECIFICALLY, BUT NOT LIMITED TO, \"ACQUIRE\", \"ENTER\" AND \"FREEZE\" BUTTON. PT SAFETY ISSUE: UNABLE TO ACQUIRE SPECIFIC IMAGE NEEDED FOR THE STUDY AT THE SPECIFIC TIME/HEART BEAT. MISSING THE IMAGE NEEDED FOR THE EXAM AFFECTS STUDY OUTCOME AND ACCREDITATION REQUIREMENTS. CARDIOLOGIST MAY REFER THE PT TO A CARDIOVASCULAR SURGEON AND VITAL INFO MAY BE MISSING ON THE EXAM, DUE TO THE MACHINE NOT ACQUIRING WHEN THE BUTTON IS PUSHED. DURING ASD CLOSURES, THE ACQUIRE BUTTON NEEDS TO ACQUIRE ON THE FIRST ATTEMPT, THE TIMING IS VITAL IN SEEING THE DEVICE. DOCUMENTATION ON THE EXAMS IS CRITICAL. THE INFO NEEDS TO BE AVAILABLE FOR PREVIOUS STUDY COMPARISON, AS WELL AS LEGAL DOCUMENTATION."
        }
      ],
      "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": ""
    }
  ]
}