{
  "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": "2026-11-04",
    "results": {
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "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": "2020676-2020-00011",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200929",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K100268",
      "date_of_event": "20200909",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "USER FACILITY"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200929",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1066100",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20200929",
          "brand_name": "4100H HBO CHMBR,ASSY,41IN,ENGLISH,BLUE,CLASSIC",
          "generic_name": "CHAMBER, HYPERBARIC",
          "manufacturer_d_name": "SECHRIST INDUSTRIES, INC",
          "manufacturer_d_address_1": "4225 E. LA PALMA AVE.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ANAHEIM",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92807",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92807",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "4100H",
          "catalog_number": "4100H",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "CBF",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
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            "fei_number": [
              "2020676"
            ],
            "device_name": "Chamber, Hyperbaric",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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        "Mechanical Problem"
      ],
      "reporter_state_code": "CA",
      "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": "20200929",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200928",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10603228",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200909",
      "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": "209184471",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE FACILITY WAS ABLE TO LOCATE THE PROBLEM, WHICH WAS A PIECE OF TUBING THAT CAME OFF THE EMERGENCY VENT BUTTON, REATTACHED TUBING AND TEST EMERGENCY VENT BUTTON FUNCTIONED AS EXPECTED. THERE WAS NO FURTHER INVESTIGATION REQUIRED BY A SECHRIST FIELD SERVICE TECHNICIAN. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. CHAMBERS ARE MULTI-USE, SERVICEABLE ITEMS. AS SUCH, IT IS ANTICIPATED THAT THE UNITS MAY OCCASIONALLY REQUIRE REPAIR, AND AS PART OF STANDARD CARE THE CHAMBERS SHOULD BE INSPECTED PRIOR TO USE. IF DAMAGE OR FUNCTIONAL ISSUES ARE NOTED DURING THESE ROUTINE CHAMBER INSPECTIONS, THE UNIT SHOULD NOT BE PUT INTO USE WITH A PATIENT AND SHOULD BE REPORTED TO SECHRIST FOR SERVICING. MANUFACTURER REFERENCE FILE#: (B)(4)."
        },
        {
          "mdr_text_key": "209184473",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING WEEKLY PERFORMANCE CHECK, IT WAS NOTED THE EMERGENCY VENT BUTTON WAS NOT WORKING WHEN THE CHAMBER WAS TESTED. THE EMERGENCY VENT TOGGLE SWITCH STILL WORK AS INTENDED AND THE CHAMBER IS STILL IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT."
        }
      ],
      "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": ""
    }
  ]
}