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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
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
Unintended Movement 15 15
Sparking 14 14
Device Slipped 9 9
Electrical Power Problem 8 8
Material Frayed 5 5
Appropriate Term/Code Not Available 4 4
Electrical Shorting 3 3
Melted 3 3
Arcing 3 3
Leak/Splash 2 2
Output Problem 2 2
Material Puncture/Hole 2 2
Smoking 2 2
No Audible Alarm 2 2
Thermal Decomposition of Device 2 2
Unintended System Motion 2 2
Device-Device Incompatibility 1 1
Unexpected Shutdown 1 1
Mechanical Problem 1 1
Unintended Electrical Shock 1 1
Defective Component 1 1
Deflation Problem 1 1
Failure to Deliver 1 1
Use of Device Problem 1 1
Flare or Flash 1 1
Decrease in Pressure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Environmental Compatibility Problem 1 1
Device Emits Odor 1 1
Material Separation 1 1
Defective Alarm 1 1
Overheating of Device 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 109
No Patient Involvement 13 13
Insufficient Information 6 6
Pressure Sores 5 5
No Known Impact Or Consequence To Patient 2 2
Unspecified Tissue Injury 2 2
Electric Shock 1 1
Foreign Body In Patient 1 1
Fall 1 1
No Consequences Or Impact To Patient 1 1

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