{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 271
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "Y",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "3010157426-2020-00008",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200701",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K103142",
      "date_of_event": "20200530",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20050101",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "COMPANY REPRESENTATIVE"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20200701",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "680386",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200701",
          "brand_name": "SPACELABS ULTRAVIEW SL COMMAND MODULE",
          "generic_name": "ULTRAVIEW SL MULTIPARAMETER MODULE",
          "manufacturer_d_name": "SPACELABS HEALTHCARE INC.",
          "manufacturer_d_address_1": "35301 SE CENTER ST.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SNOQUALMIE",
          "manufacturer_d_state": "WA",
          "manufacturer_d_zip_code": "98065",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "98065",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "91496",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "DSI",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "Y",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Detector And Alarm, Arrhythmia",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1025",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Defective Alarm"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "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": "20200701",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200630",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20050110",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10221584",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200601",
      "date_report_to_fda": "20050101",
      "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": "198720881",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE PATIENT¿S HISTORICAL DATA WAS NOT SAVED, THERE ARE NO RECORDS OF ALARMS AVAILABLE FOR THE PERIOD IN QUESTION. ON SITE TESTING OF THE INVOLVED DEVICES BY A SPACELABS FIELD SERVICE ENGINEER WERE CONDUCTED IN ACCORDANCE WITH THE PERFORMANCE TESTS LISTED IN THE SERVICE MANUAL. TESTING CONFIRMED THAT THE EQUIPMENT WORKED TO SPECIFICATIONS. ALL TESTS PASSED, INCLUDING BOTH VISIBLE AND AUDIBLE ALARM NOTIFICATIONS. NO FAILURE FOUND. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVALUATION WILL BE REVISED. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE MATTER CLOSED."
        },
        {
          "mdr_text_key": "198720882",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "SPACELABS RECEIVED A REPORT ON JUNE 1, 2020, THERE WAS NO ALARM WHEN THE PATIENT WAS CONNECTED TO THE MONITOR HAD A SPO2 SATURATION LEVEL OF 75. THE EXACT TIME OF THE EVENT IS UNKNOWN. NO INJURY WAS REPORTED AS A RESULT OF 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": ""
    }
  ]
}