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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
2015 51 51
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
Device Slipped 39 39
Material Split, Cut or Torn 34 34
Activation Problem 24 24
Unintended Movement 19 19
Sparking 15 15
Adverse Event Without Identified Device or Use Problem 13 13
Device Inoperable 11 11
Electrical Power Problem 8 8
Device Operates Differently Than Expected 7 7
Leak/Splash 7 7
Use of Device Problem 7 7
Insufficient Information 6 6
Device Displays Incorrect Message 6 6
Material Frayed 5 5
Device Alarm System 4 4
Mechanical Problem 4 4
Smoking 4 4
Loss of Power 4 4
Appropriate Term/Code Not Available 4 4
Melted 3 3
Unintended System Motion 3 3
Electrical Shorting 3 3
Arcing 3 3
Defective Component 3 3
Fail-Safe Design Failure 2 2
Thermal Decomposition of Device 2 2
Pressure Problem 2 2
Overheating of Device 2 2
Self-Activation or Keying 2 2
Device Emits Odor 2 2
Loose or Intermittent Connection 2 2
Material Puncture/Hole 2 2
Fire 2 2
Bent 2 2
Inflation Problem 2 2
Output Problem 2 2
No Audible Alarm 2 2
Unintended Head Motion 1 1
Flare or Flash 1 1
Improper Flow or Infusion 1 1
Component Missing 1 1
Human-Device Interface Problem 1 1
Electromagnetic Interference 1 1
Defective Device 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Collapse 1 1
Component Falling 1 1
Hole In 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 45 45
Pressure Sores 24 24
No Consequences Or Impact To Patient 19 19
No Patient Involvement 17 17
Injury 11 11
Fall 9 9
Insufficient Information 6 6
No Information 5 5
Electric Shock 2 2
Skin Erosion 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Brain Injury 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
Crushing Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Concussion 1 1
Shock 1 1

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