{
  "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": "Device Operates Differently Than Expected",
      "count": 3190
    },
    {
      "term": "Failure of Device to Self-Test",
      "count": 2489
    },
    {
      "term": "Incorrect, Inadequate or Imprecise Result or Readings",
      "count": 390
    },
    {
      "term": "Failure to Power Up",
      "count": 168
    },
    {
      "term": "Appropriate Device Problem Term/Code Not Available",
      "count": 130
    },
    {
      "term": "Device Displays Incorrect Message",
      "count": 107
    },
    {
      "term": "Defective Device",
      "count": 93
    },
    {
      "term": "Nonstandard Device",
      "count": 75
    },
    {
      "term": "Therapeutic or Diagnostic Output Failure",
      "count": 66
    },
    {
      "term": "Insufficient Device Problem Information",
      "count": 51
    },
    {
      "term": "Protective Measures Problem",
      "count": 34
    },
    {
      "term": "Battery Problem",
      "count": 32
    },
    {
      "term": "Failure to Run on Battery",
      "count": 29
    },
    {
      "term": "Adverse Event Without Identified Device or Use Problem",
      "count": 25
    },
    {
      "term": "Premature Discharge of Battery",
      "count": 24
    },
    {
      "term": "Failure to Deliver Shock/Stimulation",
      "count": 19
    },
    {
      "term": "Computer Operating System Problem",
      "count": 15
    },
    {
      "term": "Data Problem",
      "count": 15
    },
    {
      "term": "Defibrillation/Stimulation Problem",
      "count": 15
    },
    {
      "term": "Device Alarm System",
      "count": 14
    },
    {
      "term": "Device Inoperable",
      "count": 13
    },
    {
      "term": "Inaudible or Unclear Audible Prompt/Feedback",
      "count": 13
    },
    {
      "term": "Noise, Audible",
      "count": 12
    },
    {
      "term": "Failure to Analyze Signal",
      "count": 9
    },
    {
      "term": "No Audible Prompt/Feedback",
      "count": 9
    },
    {
      "term": "No Visual Prompts/Feedback",
      "count": 9
    },
    {
      "term": "Break",
      "count": 8
    },
    {
      "term": "Material Integrity Problem",
      "count": 8
    },
    {
      "term": "Defective Component",
      "count": 5
    },
    {
      "term": "Device Sensing Problem",
      "count": 5
    },
    {
      "term": "Display or Visual Feedback Problem",
      "count": 5
    },
    {
      "term": "Failure to Sense",
      "count": 5
    },
    {
      "term": "Material Disintegration",
      "count": 5
    },
    {
      "term": "Power Problem",
      "count": 5
    },
    {
      "term": "Connection Problem",
      "count": 4
    },
    {
      "term": "Electrical /Electronic Property Problem",
      "count": 4
    },
    {
      "term": "Inappropriate/Inadequate Shock/Stimulation",
      "count": 4
    },
    {
      "term": "Output Problem",
      "count": 4
    },
    {
      "term": "Use of Device Problem",
      "count": 4
    },
    {
      "term": "Activation, Positioning or Separation Problem",
      "count": 3
    },
    {
      "term": "Fire",
      "count": 3
    },
    {
      "term": "Inappropriate Audible Prompt/Feedback",
      "count": 3
    },
    {
      "term": "Loss of Power",
      "count": 3
    },
    {
      "term": "Naturally Worn",
      "count": 3
    },
    {
      "term": "Self-Activation or Keying",
      "count": 3
    },
    {
      "term": "Signal Artifact/Noise",
      "count": 3
    },
    {
      "term": "Visual Prompts will not Clear",
      "count": 3
    },
    {
      "term": "Communication or Transmission Problem",
      "count": 2
    },
    {
      "term": "Fail-Safe Problem",
      "count": 2
    },
    {
      "term": "Low Battery",
      "count": 2
    },
    {
      "term": "Mechanical Problem",
      "count": 2
    },
    {
      "term": "Moisture or Humidity Problem",
      "count": 2
    },
    {
      "term": "Application Interface Becomes Non-Functional Or Program Exits Abnormally",
      "count": 1
    },
    {
      "term": "Calibration Problem",
      "count": 1
    },
    {
      "term": "Charging Problem",
      "count": 1
    },
    {
      "term": "Computer Software Problem",
      "count": 1
    },
    {
      "term": "Degraded",
      "count": 1
    },
    {
      "term": "Device Expiration Issue",
      "count": 1
    },
    {
      "term": "Device Handling Problem",
      "count": 1
    },
    {
      "term": "Device Misassembled During Manufacturing /Shipping",
      "count": 1
    },
    {
      "term": "Device Operational Issue",
      "count": 1
    },
    {
      "term": "Failure to Auto Stop",
      "count": 1
    },
    {
      "term": "Failure to Shut Off",
      "count": 1
    },
    {
      "term": "Human-Device Interface Problem",
      "count": 1
    },
    {
      "term": "Improper or Incorrect Procedure or Method",
      "count": 1
    },
    {
      "term": "Inaccurate Delivery",
      "count": 1
    },
    {
      "term": "Inappropriate or Unexpected Reset",
      "count": 1
    },
    {
      "term": "Incorrect Or Inadequate Test Results",
      "count": 1
    },
    {
      "term": "Intermittent Loss of Power",
      "count": 1
    },
    {
      "term": "Key or Button Unresponsive/not Working",
      "count": 1
    },
    {
      "term": "Leak/Splash",
      "count": 1
    },
    {
      "term": "Loose or Intermittent Connection",
      "count": 1
    },
    {
      "term": "Low Audible Alarm",
      "count": 1
    },
    {
      "term": "Material Split, Cut or Torn",
      "count": 1
    },
    {
      "term": "Melted",
      "count": 1
    },
    {
      "term": "No Audible Alarm",
      "count": 1
    },
    {
      "term": "Overheating of Device",
      "count": 1
    },
    {
      "term": "Patient Device Interaction Problem",
      "count": 1
    },
    {
      "term": "Sparking",
      "count": 1
    },
    {
      "term": "Temperature Problem",
      "count": 1
    },
    {
      "term": "Unexpected Shutdown",
      "count": 1
    },
    {
      "term": "Use of Incorrect Control/Treatment Settings",
      "count": 1
    }
  ]
}