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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, air fluidized
Product CodeINX
Regulation Number 890.5160
Device Class 2

MDR Year MDR Reports MDR Events
2016 10 10
2017 28 28
2018 22 22
2019 15 15
2020 2 2
2021 2 2
2022 18 18
2023 60 60
2024 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 34 34
Activation Problem 24 24
Device Slipped 19 19
Unintended Movement 18 18
Sparking 15 15
Adverse Event Without Identified Device or Use Problem 9 9
Electrical Power Problem 8 8
Device Operates Differently Than Expected 5 5
Device Displays Incorrect Message 5 5
Material Frayed 5 5
Appropriate Term/Code Not Available 4 4
Insufficient Information 4 4
Leak/Splash 4 4
Device Inoperable 3 3
Electrical Shorting 3 3
Mechanical Problem 3 3
Use of Device Problem 3 3
Arcing 3 3
Melted 3 3
Unintended System Motion 3 3
Smoking 3 3
Loss of Power 2 2
Output Problem 2 2
Pressure Problem 2 2
Fire 2 2
Thermal Decomposition of Device 2 2
Device Alarm System 2 2
Material Puncture/Hole 2 2
No Audible Alarm 2 2
Fail-Safe Design Failure 2 2
Self-Activation or Keying 2 2
Inflation Problem 2 2
Overheating of Device 2 2
Defective Component 2 2
Improper Flow or Infusion 1 1
Flare or Flash 1 1
Decrease in Pressure 1 1
Component Falling 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Environmental Compatibility Problem 1 1
Defective Alarm 1 1
Material Separation 1 1
Device Emits Odor 1 1
Difficult To Position 1 1
Air Leak 1 1
Deflation Problem 1 1
Failure to Deliver 1 1
Unintended Electrical Shock 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 109
No Known Impact Or Consequence To Patient 23 23
Pressure Sores 20 20
No Patient Involvement 17 17
Injury 7 7
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
Fall 3 3
No Information 2 2
Skin Erosion 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Electric Shock 1 1
Brain Injury 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
Crushing Injury 1 1
Foreign Body In Patient 1 1
Concussion 1 1
Shock 1 1

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