{
  "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": "2026-10-13"
  },
  "results": [
    {
      "term": "Therapeutic or Diagnostic Output Failure",
      "count": 556
    },
    {
      "term": "Mechanical Problem",
      "count": 392
    },
    {
      "term": "Insufficient Flow or Under Infusion",
      "count": 225
    },
    {
      "term": "No Display/Image",
      "count": 160
    },
    {
      "term": "Gas/Air Leak",
      "count": 151
    },
    {
      "term": "Device Operates Differently Than Expected",
      "count": 135
    },
    {
      "term": "Unexpected Therapeutic Results",
      "count": 135
    },
    {
      "term": "Appropriate Device Problem Term/Code Not Available",
      "count": 122
    },
    {
      "term": "Increase in Pressure",
      "count": 121
    },
    {
      "term": "Infusion or Flow Problem",
      "count": 119
    },
    {
      "term": "Failure to Run on Battery",
      "count": 108
    },
    {
      "term": "Break",
      "count": 95
    },
    {
      "term": "Unexpected Shutdown",
      "count": 80
    },
    {
      "term": "Decrease in Suction",
      "count": 66
    },
    {
      "term": "Output Problem",
      "count": 65
    },
    {
      "term": "Pressure Problem",
      "count": 62
    },
    {
      "term": "Suction Failure",
      "count": 53
    },
    {
      "term": "Device Displays Incorrect Message",
      "count": 47
    },
    {
      "term": "No Audible Alarm",
      "count": 43
    },
    {
      "term": "Electrical /Electronic Property Problem",
      "count": 40
    },
    {
      "term": "Suction Problem",
      "count": 39
    },
    {
      "term": "Leak/Splash",
      "count": 33
    },
    {
      "term": "No Visual Prompts/Feedback",
      "count": 31
    },
    {
      "term": "Device Alarm System",
      "count": 30
    },
    {
      "term": "Power Problem",
      "count": 30
    },
    {
      "term": "Device Inoperable",
      "count": 28
    },
    {
      "term": "Physical Resistance/Sticking",
      "count": 28
    },
    {
      "term": "Inaccurate Delivery",
      "count": 27
    },
    {
      "term": "Gas Output Problem",
      "count": 23
    },
    {
      "term": "Device Sensing Problem",
      "count": 21
    },
    {
      "term": "Misconnection",
      "count": 21
    },
    {
      "term": "Circuit Failure",
      "count": 20
    },
    {
      "term": "Incorrect Measurement",
      "count": 20
    },
    {
      "term": "Energy Output Problem",
      "count": 17
    },
    {
      "term": "Excess Flow or Over-Infusion",
      "count": 17
    },
    {
      "term": "Inappropriate or Unexpected Reset",
      "count": 17
    },
    {
      "term": "Failure to Power Up",
      "count": 16
    },
    {
      "term": "Detachment of Device or Device Component",
      "count": 11
    },
    {
      "term": "Mechanical Jam",
      "count": 11
    },
    {
      "term": "Loss of Power",
      "count": 10
    },
    {
      "term": "Tidal Volume Fluctuations",
      "count": 8
    },
    {
      "term": "Battery Problem",
      "count": 7
    },
    {
      "term": "Sticking",
      "count": 7
    },
    {
      "term": "Contamination",
      "count": 6
    },
    {
      "term": "Decrease in Pressure",
      "count": 6
    },
    {
      "term": "Device Fell",
      "count": 6
    },
    {
      "term": "Insufficient Device Problem Information",
      "count": 6
    },
    {
      "term": "Adverse Event Without Identified Device or Use Problem",
      "count": 5
    },
    {
      "term": "Crack",
      "count": 5
    },
    {
      "term": "Incorrect, Inadequate or Imprecise Result or Readings",
      "count": 5
    },
    {
      "term": "No Flow",
      "count": 5
    },
    {
      "term": "Complete Loss of Power",
      "count": 4
    },
    {
      "term": "Defective Alarm",
      "count": 4
    },
    {
      "term": "Failure to Deliver",
      "count": 4
    },
    {
      "term": "High Readings",
      "count": 4
    },
    {
      "term": "Improper Flow or Infusion",
      "count": 3
    },
    {
      "term": "Material Integrity Problem",
      "count": 3
    },
    {
      "term": "Air Leak",
      "count": 2
    },
    {
      "term": "Device Stops Intermittently",
      "count": 2
    },
    {
      "term": "Inflation Problem",
      "count": 2
    },
    {
      "term": "Noise, Audible",
      "count": 2
    },
    {
      "term": "Operating System Becomes Nonfunctional",
      "count": 2
    },
    {
      "term": "Partial Blockage",
      "count": 2
    },
    {
      "term": "Protective Measures Problem",
      "count": 2
    },
    {
      "term": "Activation Problem",
      "count": 1
    },
    {
      "term": "Alarm Not Visible",
      "count": 1
    },
    {
      "term": "Calibration Problem",
      "count": 1
    },
    {
      "term": "Computer Operating System Problem",
      "count": 1
    },
    {
      "term": "Computer Software Problem",
      "count": 1
    },
    {
      "term": "Data Problem",
      "count": 1
    },
    {
      "term": "Defective Component",
      "count": 1
    },
    {
      "term": "Defective Device",
      "count": 1
    },
    {
      "term": "Deformation Due to Compressive Stress",
      "count": 1
    },
    {
      "term": "Device Damaged Prior to Use",
      "count": 1
    },
    {
      "term": "Device Difficult to Program or Calibrate",
      "count": 1
    },
    {
      "term": "Device Tipped Over",
      "count": 1
    },
    {
      "term": "Difficult or Delayed Activation",
      "count": 1
    },
    {
      "term": "Disconnection",
      "count": 1
    },
    {
      "term": "Display or Visual Feedback Problem",
      "count": 1
    },
    {
      "term": "Failure of Device to Self-Test",
      "count": 1
    },
    {
      "term": "Failure to Sense",
      "count": 1
    },
    {
      "term": "Fitting Problem",
      "count": 1
    },
    {
      "term": "Fluid/Blood Leak",
      "count": 1
    },
    {
      "term": "Image Display Error/Artifact",
      "count": 1
    },
    {
      "term": "Improper or Incorrect Procedure or Method",
      "count": 1
    },
    {
      "term": "Inadequate Lighting",
      "count": 1
    },
    {
      "term": "Intermittent Loss of Power",
      "count": 1
    },
    {
      "term": "Loose or Intermittent Connection",
      "count": 1
    },
    {
      "term": "Low Readings",
      "count": 1
    },
    {
      "term": "Moisture or Humidity Problem",
      "count": 1
    },
    {
      "term": "No Apparent Adverse Event",
      "count": 1
    },
    {
      "term": "Nonstandard Device",
      "count": 1
    },
    {
      "term": "Obstruction of Flow",
      "count": 1
    },
    {
      "term": "Occlusion Within Device",
      "count": 1
    },
    {
      "term": "Output above Specifications",
      "count": 1
    },
    {
      "term": "Output below Specifications",
      "count": 1
    },
    {
      "term": "Pressure, insufficient",
      "count": 1
    },
    {
      "term": "Program or Algorithm Execution Problem",
      "count": 1
    },
    {
      "term": "Reset Problem",
      "count": 1
    },
    {
      "term": "Restricted Flow rate",
      "count": 1
    }
  ]
}