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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
Product CodeGBB
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 3 3
2021 13 13
2022 4 4
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 5 5
Unintended Movement 4 4
Electromagnetic Compatibility Problem 3 3
Mechanical Problem 3 3
Unintended Electrical Shock 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Device Slipped 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Handling 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) 2 2
Laceration(s) 2 2
Death 2 2
Pain 1 1
Physical Entrapment 1 1
Injury 1 1
Hip Fracture 1 1
Hypoxia 1 1
Patient Problem/Medical Problem 1 1
Unspecified Tissue Injury 1 1

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