{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "HOSPITAL",
      "report_to_fda": "Y",
      "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": "Malfunction",
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      "type_of_report": [
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      "date_received": "20220301",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20220215",
      "reprocessed_and_reused_flag": "N",
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      "report_date": "20220216",
      "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": [
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      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20220301",
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      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1793991",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20220301",
          "brand_name": "KENDALL SCD 700 SEQUENTIAL COMPRESSION SYSTEM",
          "generic_name": "SLEEVE, LIMB, COMPRESSIBLE",
          "manufacturer_d_name": "CARDINAL HEALTH, INC.",
          "manufacturer_d_address_1": "15 HAMPSHIRE STREET",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MANSFIELD",
          "manufacturer_d_state": "MA",
          "manufacturer_d_zip_code": "02048",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "02048",
          "device_operator": "",
          "model_number": "29525",
          "catalog_number": "29525",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "JOW",
          "device_age_text": "5 YR",
          "device_evaluated_by_manufacturer": "*",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Sleeve, Limb, Compressible",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.5800",
            "device_class": "2"
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        }
      ],
      "product_problems": [
        "No Audible Alarm",
        "Failure to Run on Battery",
        "No Audible Alarm",
        "Failure to Run on Battery"
      ],
      "reporter_state_code": "MN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250808",
      "health_professional": "Y",
      "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": "20220301",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220216",
      "initial_report_to_fda": "Yes",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20220301",
      "manufacturer_contact_city": "",
      "mdr_report_key": "13634140",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20220216",
      "manufacturer_name": "",
      "report_source_code": "User Facility 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": "286339293",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SCD MACHINE WAS ON AND WORKING AT THE BEGINNING OF THE SURGICAL CASE. NEAR THE END OF THE CASE, I NOTICED THE MACHINE WAS NO LONGER ON. NURSE WENT TO TURN IT ON AND IT WOULD NOT TURN ON, AS THE BATTERY WAS DEAD. MACHINE DID NOT ALARM DUE TO LOW BATTERY LIKE IT NORMALLY DOES. ALARMS FAILED TO SOUND TO ALERT STAFF THE MACHINE HAD STOPPED WORKING."
        },
        {
          "mdr_text_key": "288384177",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SCD MACHINE WAS ON AND WORKING AT THE BEGINNING OF THE SURGICAL CASE. NEAR THE END OF THE CASE, I NOTICED THE MACHINE WAS NO LONGER ON. NURSE WENT TO TURN IT ON AND IT WOULD NOT TURN ON, AS THE BATTERY WAS DEAD. MACHINE DID NOT ALARM DUE TO LOW BATTERY LIKE IT NORMALLY DOES. ALARMS FAILED TO SOUND TO ALERT STAFF THE MACHINE HAD STOPPED WORKING."
        }
      ],
      "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": ""
    }
  ]
}