{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
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      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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      "manufacturer_contact_plocal": "",
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        ""
      ],
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20200429",
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        {
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          "serviced_by_3rd_party_flag": "",
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          "brand_name": "MAC",
          "generic_name": "ELECTROCARDIOGRAPH",
          "manufacturer_d_name": "GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.",
          "manufacturer_d_address_1": "8200 WEST TOWER AVENUE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MILWAUKEE",
          "manufacturer_d_state": "WI",
          "manufacturer_d_zip_code": "53223",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "lot_number": "",
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          "device_report_product_code": "DPS",
          "device_age_text": "1 YR",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Electrocardiograph",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2340",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "OR",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "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": "20200429",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
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          "patient_sex": "",
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          "patient_problems": [
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            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200302",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20200429",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10009045",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20200302",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "N",
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      "manufacturer_state": "",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "189329634",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE NEW EKG MACHINES DO NOT HAVE A HARD STOP REQUIRING STAFF TO ENTER A PATIENT IDENTIFIER. THE URGENCY TO PERFORM THE EKG ALLOWED THE CAREGIVER TO BY-PASS THE FIELD TO ENTER IN PATIENT DATA. THE TEST WAS RUN BUT THE REPORT COULD NOT BE RELIABLY LINKED TO THE PATIENT BECAUSE NO PATIENT INFORMATION WAS ENTERED PRIOR TO RUNNING THE EKG."
        }
      ],
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}