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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, surgical, ac-powered
Regulation Description Operating tables and accessories and operating chairs and accessories.
Product CodeGBB
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2021 13 13
2022 4 4
2023 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 4 4
Mechanical Problem 3 3
Unintended Electrical Shock 3 3
Electromagnetic Compatibility Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Device Fell 2 2
Unintended System Motion 2 2
Device Slipped 1 1
Collapse 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Fall 4 4
Electric Shock 3 3
Bone Fracture(s) 3 3
Insufficient Information 1 1
Pain 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

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