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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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 31 31
Activation Problem 21 21
Unintended Movement 15 15
Sparking 13 13
Device Slipped 9 9
Electrical Power Problem 8 8
Appropriate Term/Code Not Available 4 4
Material Frayed 4 4
Melted 3 3
Arcing 3 3
Material Puncture/Hole 2 2
Smoking 2 2
Unintended System Motion 2 2
Leak/Splash 2 2
No Audible Alarm 2 2
Thermal Decomposition of Device 2 2
Electrical Shorting 2 2
Output Problem 2 2
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Environmental Compatibility Problem 1 1
Flare or Flash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Noise, Audible 1 1
Device-Device Incompatibility 1 1
Deflation Problem 1 1
Mechanical Problem 1 1
Overheating of Device 1 1
Decrease in Pressure 1 1
Device Emits Odor 1 1
Use of Device Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Material Separation 1 1
Defective Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
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
Foreign Body In Patient 1 1
Electric Shock 1 1
Fall 1 1
No Consequences Or Impact To Patient 1 1

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