{
  "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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      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Other",
      "report_number": "MW5007614",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20080711",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20080429",
      "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",
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      "source_type": [
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      ],
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      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20080718",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080711",
          "brand_name": "GE MAC 5500",
          "generic_name": "10 LEAD EKG CART",
          "manufacturer_d_name": "GENERAL ELECTRIC",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "WAUKESHA",
          "manufacturer_d_state": "WI",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "MAC 5500",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "DPS",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Electrocardiograph",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2340",
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          }
        }
      ],
      "product_problems": [
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        "Labeling, missing"
      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "health_professional": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20080711",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unknown (for use when the patient's condition is not known)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080711",
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      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1075392",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
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      ],
      "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": "17067494",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WE BECAME AWARE OF SOME INTERFERENCE WITH THE DIAGNOSTIC ACCURACY OF ELECTROCARDIOGRAMS PERFORMED IN THE EMERGENCY DEPT, OVER THE TIME PERIOD OF 5 DAYS: 2008. UPON REVIEW OF THE EKGS BY AN INDEPENDENT CARDIOLOGIST, THE FOLLOWING ISSUES WERE IDENTIFIED: THE LEAD WIRES WERE MISCONNECTED TO THE ACQUISITION MODULE OF THE MAC CART; THE NON-LABELED FEATURE OF THE PROXIMAL END OF THE LEAD WIRES CONTRIBUTED TO THE MISCONNECTION OF THE LEAD WIRES; THE DEVICE SOFTWARE WAS INCONSISTENT IN GIVING ERROR MESSAGES OF SUSPECTED LIMB LEAD REVERSAL ON THE EKG TRACING. IN LIGHT OF THE FACT THAT THERE IS NO VISIBLE LABELING ON THE PROXIMAL ENDS OF THE LEAD WIRES CONNECTED TO THE ACQUISITION MODULE OF THE MAC CART, THE POSSIBLE MISCONNECTION OF A LEAD WIRE IS NOT EASILY DETECTABLE BY A USER. AS, IN SOME CIRCUMSTANCES, AN EKG IS A DEFINITIVE TEST, POTENTIAL ADVERSE EVENTS - E.G., HOSPITALIZATION, INTERVENTION, INAPPROPRIATE DISCHARGE- COULD OCCUR."
        }
      ],
      "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": ""
    }
  ]
}