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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
2017 28 28
2018 22 22
2019 15 15
2020 2 2
2021 2 2
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 17 17
Adverse Event Without Identified Device or Use Problem 8 8
Device Displays Incorrect Message 4 4
Insufficient Information 4 4
Mechanical Problem 3 3
Electrical Power Problem 3 3
Unintended System Motion 3 3
Device Inoperable 3 3
Unintended Movement 3 3
Device Operates Differently Than Expected 3 3
Fire 2 2
Pressure Problem 2 2
Defective Component 2 2
Fail-Safe Design Failure 2 2
Leak/Splash 2 2
Self-Activation or Keying 2 2
Appropriate Term/Code Not Available 2 2
Material Puncture/Hole 2 2
Material Split, Cut or Torn 1 1
Melted 1 1
Difficult To Position 1 1
No Audible Alarm 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Unintended Head Motion 1 1
Smoking 1 1
Use of Device Problem 1 1
Failure to Deliver 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Temperature Problem 1 1
Torn Material 1 1
Device Alarm System 1 1
Defective Alarm 1 1
Component Falling 1 1
Electrical /Electronic Property Problem 1 1
Positioning Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device-Device Incompatibility 1 1
Electronic Property Issue 1 1
Loss of Power 1 1
Device Issue 1 1
Sparking 1 1
Environmental Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 17 17
Pressure Sores 13 13
Injury 7 7
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Skin Erosion 2 2
Fall 2 2
Pain 2 2
Shock 1 1
Bone Fracture(s) 1 1
Concussion 1 1
Brain Injury 1 1
Foreign Body In Patient 1 1
No Information 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Crushing Injury 1 1

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