{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "N",
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      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "report_number": "3019216-2020-00025",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "date_received": "20200501",
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      "pma_pmn_number": "K163120",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
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      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "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": "483111",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200501",
          "brand_name": "TRANSDUCER X8-2T",
          "generic_name": "TRANSDUCER",
          "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": "989605455171",
          "catalog_number": "",
          "lot_number": "B3J4LK",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20200504",
          "device_report_product_code": "ITX",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00884838069718",
          "udi_public": "(01)00884838069718",
          "openfda": {
            "registration_number": [
              "3019216"
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            "fei_number": [
              "3019216"
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            "device_name": "Transducer, Ultrasonic, Diagnostic",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.1570",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Mechanical Problem"
      ],
      "reporter_state_code": "KS",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/10/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "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": [
            ""
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            ""
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200410",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10017640",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200410",
      "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": "316512729",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "EVALUATION OF THE X8-2T MODEL TRANSDUCER CONFIRMED THE PROBE HAD LOST ITS ABILITY TO ARTICULATE. A THOROUGH FUNCTIONAL AND VISUAL INSPECTION REVEALED THE STEERING CABLE USED TO CREATE MOVEMENT IN THE BENDING NECK HAD PULLED OUT OF THE DISTAL FERRULE. THE DISTAL FERRULE IS SWAGED OR CRIMPED ONTO THE STEERING CABLE BY THE VENDOR, AND THE INVESTIGATION CONCLUDED THIS PROCESS WAS PERFORMED INCORRECTLY. A SUPPLIER CHANGE ASSESSMENT (SCA) HAS BEEN INITIATED TO INCREASE THE SAMPLE SIZE FOR A DESTRUCTIVE TENSILE STRENGTH TEST WHICH WILL VALIDATE THE FERRULE SWAGE AND CRIMP IN FUTURE MANUFACTURING. 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."
        },
        {
          "mdr_text_key": "190143096",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "RETURN OF THE SUSPECT TRANSDUCER IS ANTICIPATED. EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION."
        },
        {
          "mdr_text_key": "190143097",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A CUSTOMER REPORTED AN X8-2T MODEL TRANSDUCER HAD A PARTIAL LOSS OF ARTICULATION DURING USE. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY WITH NO NEGATIVE PATIENT OUTCOME. THERE WAS NO INJURY ASSOCIATED WITH THIS 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": "05/20/2020"
    }
  ]
}