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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
Product CodeKZF
Regulation Number 880.6320
Device Class 1

MDR Year MDR Reports MDR Events
2019 27 27
2020 47 47
2021 21 21
2022 70 70
2023 84 84
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 156 156
Crack 87 87
Break 45 45
Fracture 15 15
Device Fell 8 8
Peeled/Delaminated 5 5
Component Missing 4 4
Installation-Related Problem 4 4
Fire 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 2 2
Smoking 2 2
Corroded 2 2
Mechanical Problem 1 1
Flare or Flash 1 1
Use of Device Problem 1 1
Electromagnetic Interference 1 1
Melted 1 1
Temperature Problem 1 1
Fluid/Blood Leak 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Sparking 1 1
Operating System Becomes Nonfunctional 1 1
Fitting Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Collapse 1 1
Defective Component 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
No Patient Involvement 39 39
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 11 11
Laceration(s) 3 3
Superficial (First Degree) Burn 2 2
Burn, Thermal 2 2
No Information 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Fall 1 1
Cancer 1 1

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