{
  "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": "2026-05-12",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "k060542",
      "date_of_event": "20070108",
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          "manufacturer_d_address_1": "*",
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          "manufacturer_d_city": "HORTEN",
          "manufacturer_d_state": "",
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          "manufacturer_d_zip_code_ext": "91",
          "manufacturer_d_country": "NO",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "*",
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      ],
      "distributor_city": "",
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      "mdr_report_key": "823519",
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      "manufacturer_zip_code_ext": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "585967",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED TO GE THAT THE ULTRASOUND SYSTEM LOCKED-UP DURING SURGERY, RESULTING IN LOSS OF IMAGES AND USE OF A BACK-UP UNIT. NO INJURY WAS REPORTED. THE DELAY WITH EXTENDED TIME UNDER ANESTHESIA AND CARDIAC BYPASS MAY CONTRIBUTE TO INJURY, SHOULD A SIMILAR MALFUNCTION RECUR."
        }
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      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}