{
  "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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      "date_changed": "20250730",
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      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
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      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
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      "single_use_flag": "",
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      "mdr_text": [
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          "mdr_text_key": "20995312",
          "text_type_code": "Description of Event or Problem",
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          "text": "THE PULSE MEASUREMENT HAD SOME PROBLEMS USING SPO2. EVEN THOUGH THE PATIENT HAD NO PULSE DEFICIENCY AND THE SYSTOLIC SOUND (PULSE TONE PROVIDED BY THE SPO2 MEASUREMENT) WAS GIVEN WITH EVERY PULSE WAVE, THE DISPLAYED PULSE VALUE WAS FROZEN TO A CONSTANT VALUE FOR AT LEAST FIVE MINUTES. THE VALUE STAYED FROZEN EVEN THOUGH ATROPINE WAS GIVEN TO THE PATIENT AND THE REAL PULSE FREQUENCY ROSE FROM BELOW 50 UP TO ABOUT 60. THE PULSE FREQUENCY WAS DETERMINED CORRECTLY BY THE ECG. A SWITCHING OF THE SETTINGS FROM NORMAL TO FAST \"MITTELWERTBILDUNG\" (ENGL. AVERAGING MODE\") DIDN'T CHANGE ANYTHING AT IT."
        },
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          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "WE ARE IN PROCESS OF GATHERING ADDITIONAL INFORMATION FROM THE CUSTOMER ABOUT THE INCIDENT INCLUDING PLACEMENTS OF THE SENSORS AND THE SPECIFIC EVENTS THAT TOOK PLACE AT THE TIME OF THE INCIDENT. WE NEED THIS INFORMATION FOR EFFECTIVE INVESTIGATION AND TO IDENTIFY THE CAUSE OF THE PRODUCT PROBLEM."
        }
      ],
      "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": ""
    }
  ]
}