HIGH FLOW INSUFFLATION UNIT
This device is manufactured by AIZU OLYMPUS CO, OLYMPUS AMERICA, OLYMPUS MEDICAL SYSTEMS CORP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Pneumothorax | 1 | Patient |
| 2024 | Memory Loss/Impairment | 1 | Patient |
| 2024 | Hemorrhagic Stroke | 1 | Patient |
| 2024 | Electrolyte Imbalance | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Abdominal Pain | 1 | Patient |
| 2024 | Abdominal Distention | 1 | Patient |
| 2024 | Unexpected Shutdown | 1 | Device |
| 2024 | Pressure Problem | 29 | Device |
| 2024 | Power Problem | 4 | Device |
| 2024 | Poor Quality Image | 3 | Device |
| 2024 | Output Problem | 7 | Device |
| 2024 | Noise, Audible | 2 | Device |
| 2024 | No Visual Prompts/Feedback | 15 | Device |
| 2024 | No Pressure | 1 | Device |
| 2024 | No Flow | 1 | Device |
| 2024 | No Display/Image | 21 | Device |
| 2024 | No Device Output | 5 | Device |
| 2024 | No Audible Alarm | 1 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Loss of Power | 3 | Device |
| 2024 | Leak/Splash | 8 | Device |
| 2024 | Intermittent Loss of Power | 1 | Device |
| 2024 | Insufficient Flow or Under Infusion | 6 | Device |
| 2024 | Infusion or Flow Problem | 1 | Device |
| 2024 | Inflation Problem | 2 | Device |
| 2024 | Increase in Pressure | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2024 | Inaccurate Flow Rate | 2 | Device |
| 2024 | Improper Flow or Infusion | 1 | Device |
| 2024 | Gas/Air Leak | 12 | Device |
| 2024 | Gas Output Problem | 5 | Device |
| 2024 | Free or Unrestricted Flow | 4 | Device |
| 2024 | Fitting Problem | 1 | Device |
| 2024 | Failure to Power Up | 10 | Device |
| 2024 | Failure to Clean Adequately | 1 | Device |
| 2024 | Failure to Auto Stop | 1 | Device |
| 2024 | Fail-Safe Did Not Operate | 2 | Device |
| 2024 | Excess Flow or Over-Infusion | 3 | Device |
| 2024 | Electrical Power Problem | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 5 | Device |
| 2024 | Dull, Blunt | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 3 | Device |
| 2024 | Device Difficult to Program or Calibrate | 1 | Device |
| 2024 | Device Alarm System | 3 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Defective Component | 5 | Device |
| 2024 | Defective Alarm | 1 | Device |
| 2024 | Decrease in Pressure | 1 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Crack | 1 | Device |
| 2024 | Corroded | 1 | Device |
| 2024 | Component Missing | 1 | Device |
| 2024 | Complete Loss of Power | 1 | Device |
| 2024 | Communication or Transmission Problem | 2 | Device |
| 2024 | Break | 8 | Device |
| 2024 | Audible Prompt/Feedback Problem | 9 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Air Embolism | 1 | Patient |
| 2023 | Unexpected Shutdown | 2 | Device |
| 2023 | Suction Failure | 1 | Device |
| 2023 | Restricted Flow rate | 1 | Device |
| 2023 | Pressure Problem | 35 | Device |
| 2023 | Power Problem | 5 | Device |
| 2023 | Output Problem | 2 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Visual Prompts/Feedback | 7 | Device |
| 2023 | No Flow | 1 | Device |
| 2023 | No Display/Image | 18 | Device |
| 2023 | No Device Output | 5 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Loss of Power | 11 | Device |
| 2023 | Loose or Intermittent Connection | 1 | Device |
| 2023 | Key or Button Unresponsive/not Working | 3 | Device |
| 2023 | Intermittent Loss of Power | 5 | Device |
| 2023 | Insufficient Flow or Under Infusion | 2 | Device |
| 2023 | Inflation Problem | 2 | Device |
| 2023 | Increase in Suction | 1 | Device |
| 2023 | Increase in Pressure | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2023 | Inaccurate Flow Rate | 3 | Device |
| 2023 | Improper Flow or Infusion | 1 | Device |
| 2023 | Gas/Air Leak | 9 | Device |
| 2023 | Gas Output Problem | 7 | Device |
| 2023 | Free or Unrestricted Flow | 2 | Device |
| 2023 | Failure to Power Up | 6 | Device |
| 2023 | Failure to Clean Adequately | 1 | Device |
| 2023 | Fail-Safe Did Not Operate | 2 | Device |
| 2023 | Excess Flow or Over-Infusion | 2 | Device |
| 2023 | Electrical Power Problem | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 7 | Device |
| 2023 | Display or Visual Feedback Problem | 16 | Device |
| 2023 | Device Alarm System | 9 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Defective Component | 9 | Device |
| 2023 | Decrease in Pressure | 1 | Device |
| 2023 | Crack | 1 | Device |
| 2023 | Contamination | 1 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Component Missing | 2 | Device |
| 2023 | Complete Loss of Power | 1 | Device |
| 2023 | Communication or Transmission Problem | 7 | Device |
| 2023 | Circuit Failure | 4 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Audible Prompt/Feedback Problem | 12 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Unexpected Shutdown | 4 | Device |
| 2022 | Suction Problem | 1 | Device |
| 2022 | Pressure Problem | 15 | Device |
| 2022 | Premature Activation | 1 | Device |
| 2022 | Power Problem | 3 | Device |
| 2022 | Output above Specifications | 1 | Device |
| 2022 | Output Problem | 3 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | Noise, Audible | 4 | Device |
| 2022 | No Display/Image | 16 | Device |
| 2022 | No Device Output | 2 | Device |
| 2022 | No Audible Alarm | 1 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Loss of Power | 4 | Device |
| 2022 | Leak/Splash | 3 | Device |
| 2022 | Intermittent Loss of Power | 3 | Device |
| 2022 | Insufficient Flow or Under Infusion | 2 | Device |
| 2022 | Infusion or Flow Problem | 2 | Device |
| 2022 | Inflation Problem | 1 | Device |
| 2022 | Increase in Pressure | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2022 | Gas/Air Leak | 3 | Device |
| 2022 | Gas Output Problem | 3 | Device |
| 2022 | Free or Unrestricted Flow | 1 | Device |
| 2022 | Failure to Power Up | 7 | Device |
| 2022 | Failure to Clean Adequately | 2 | Device |
| 2022 | Fail-Safe Did Not Operate | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 2 | Device |
| 2022 | Erratic or Intermittent Display | 3 | Device |
| 2022 | Electrical /Electronic Property Problem | 6 | Device |
| 2022 | Display or Visual Feedback Problem | 16 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Alarm System | 3 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 3 | Device |
| 2022 | Defective Alarm | 1 | Device |
| 2022 | Decrease in Pressure | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Contamination | 3 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Computer Operating System Problem | 1 | Device |
| 2022 | Complete Loss of Power | 2 | Device |
| 2022 | Communication or Transmission Problem | 5 | Device |
| 2022 | Circuit Failure | 3 | Device |
| 2022 | Break | 1 | Device |
| 2021 | Unexpected Shutdown | 1 | Device |
| 2021 | Pressure Problem | 1 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2021 | Disconnection | 1 | Device |
| 2020 | Gas Output Problem | 1 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Unintended Movement | 1 | Device |
| 2019 | No Flow | 3 | Device |
| 2019 | Insufficient Information | 3 | Device |
| 2019 | Infusion or Flow Problem | 2 | Device |
| 2019 | Increase in Pressure | 2 | Device |
| 2019 | Improper Flow or Infusion | 3 | Device |
| 2019 | Failure to Power Up | 1 | Device |
| 2019 | Device Operates Differently Than Expected | 4 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Unintended Movement | 1 | Device |
| 2018 | Power Problem | 1 | Device |
| 2018 | No Flow | 1 | Device |
| 2018 | Infusion or Flow Problem | 3 | Device |
| 2018 | Improper Flow or Infusion | 7 | Device |
| 2018 | Device Operates Differently Than Expected | 5 | Device |
| 2018 | Circuit Failure | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Electrical /Electronic Property Problem | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Improper Flow or Infusion | 3 | Device |
| 2016 | Gas/Air Leak | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 3 | Device |
| 2015 | Improper Flow or Infusion | 3 | Device |