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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, floor standing
Product CodeFSS
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 13 13
2020 9 9
2021 5 5
2022 3 3
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 24 24
Crack 10 10
Break 9 9
Improper or Incorrect Procedure or Method 6 6
Mechanical Problem 3 3
Peeled/Delaminated 3 3
Failure to Power Up 2 2
Melted 2 2
Fracture 2 2
Material Split, Cut or Torn 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Unexpected Shutdown 1 1
Defective Device 1 1
Device Tipped Over 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 8 8
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 7 7
Patient Problem/Medical Problem 1 1

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