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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, medical examination, ac powered
Regulation Description AC-powered medical examination light.
Product CodeKZF
Regulation Number 880.6320
Device Class 1

MDR Year MDR Reports MDR Events
2020 47 47
2021 21 21
2022 70 70
2023 84 84
2024 20 20
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 151 151
Crack 87 87
Break 32 32
Fracture 15 15
Device Fell 6 6
Material Split, Cut or Torn 5 5
Peeled/Delaminated 4 4
Installation-Related Problem 4 4
Fire 2 2
Insufficient Information 2 2
Smoking 2 2
Fitting Problem 1 1
Sparking 1 1
Unintended Movement 1 1
Defective Component 1 1
Use of Device Problem 1 1
Component Missing 1 1
Flare or Flash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Material Separation 1 1
No Apparent Adverse Event 1 1
Electromagnetic Interference 1 1
Melted 1 1
Corroded 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 188 188
No Patient Involvement 37 37
No Consequences Or Impact To Patient 10 10
Superficial (First Degree) Burn 2 2
Laceration(s) 2 2
No Information 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Fall 1 1
Cancer 1 1

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