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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stool, operating-room
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeFZM
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2017 14 14
2018 17 17
2019 4 10
2020 13 26
2021 3 4

Device Problems MDRs with this Device Problem Events in those MDRs
Brake 10 10
Device Slipped 9 18
Device Operates Differently Than Expected 9 9
Unintended Movement 7 13
Unstable 6 11
Break 5 5
Tip 5 5
Component Missing 4 4
Mechanical Problem 4 4
Device Fell 4 4
Jack 3 3
Loose or Intermittent Connection 2 2
Material Integrity Problem 2 2
Mechanics Altered 1 1
Positioning Problem 1 1
Device Tipped Over 1 1
Connection Problem 1 1
Sharp Edges 1 1
Fitting Problem 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Patient Involvement 15 26
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 15
Fall 1 2

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