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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, electroconvulsive therapy
Regulation Description Electroconvulsive therapy device.
Product CodeGXC
Regulation Number 882.5940
Device Class 3

MDR Year MDR Reports MDR Events
2015 2 2
2016 6 6
2017 2 2
2018 15 15
2019 16 16
2020 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 38 38
Patient-Device Incompatibility 12 12
Insufficient Information 5 5
Device Operates Differently Than Expected 2 2
Device Operational Issue 2 2
Human-Device Interface Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Detachment of Device or Device Component 1 1
Pad 1 1
Smoking 1 1
Sparking 1 1
Detachment Of Device Component 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Memory Loss/Impairment 37 37
Cognitive Changes 21 21
Depression 20 20
Brain Injury 8 8
Injury 7 7
Confusion/ Disorientation 7 7
Headache 7 7
Emotional Changes 7 7
Nausea 5 5
No Code Available 5 5
Pain 4 4
Seizures 3 3
Dizziness 3 3
Anxiety 3 3
Disability 3 3
Distress 2 2
Shaking/Tremors 2 2
No Information 2 2
Loss of Vision 2 2
Vomiting 2 2
Retinal Detachment 2 2
Death 2 2
Sleep Dysfunction 2 2
Ambulation Difficulties 1 1
Erythema 1 1
No Known Impact Or Consequence To Patient 1 1
Rash 1 1
Skin Irritation 1 1
Therapeutic Effects, Unexpected 1 1
Transient Ischemic Attack 1 1
Hernia 1 1
Loss of consciousness 1 1
Neck Pain 1 1
Bone Fracture(s) 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Intraocular Pressure Increased 1 1
Paralysis 1 1
Respiratory Distress 1 1
Scarring 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Syncope 1 1
Arthralgia 1 1
Therapeutic Response, Decreased 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
High Pulmonary Arterial Wedge Pressure 1 1

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