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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lamp, operating-room
Product CodeFQP
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 18 18
2019 1 1
2020 19 19
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 15 15
Device Issue 10 10
Component Falling 9 9
Degraded 6 6
Flaked 6 6
Compatibility Problem 6 6
Material Integrity Problem 6 6
Mechanical Problem 4 4
Detachment of Device or Device Component 3 3
Break 2 2
Detachment Of Device Component 1 1
Device Operates Differently Than Expected 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Device Dislodged or Dislocated 1 1
Facilities Issue 1 1
Melted 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Device Maintenance Issue 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 6 6
No Clinical Signs, Symptoms or Conditions 5 5
No Code Available 1 1
Insufficient Information 1 1

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