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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
Regulation Description Air-fluidized bed.
Product CodeINX
Regulation Number 890.5160
Device Class 2

Device Problems
Device Inoperable 9
Adverse Event Without Identified Device or Use Problem 9
Use of Device Problem 6
Insufficient Information 4
Pressure Problem 2
Unintended Movement 2
Detachment Of Device Component 1
Leak / Splash 1
Air Leak 1
Device Issue 1
Break 1
Collapse 1
Mechanical Problem 1
Defective Device 1
Improper Flow or Infusion 1
Temperature Problem 1
Torn Material 1
Device Alarm System 1
Component Falling 1
Device Displays Incorrect Message 1
Defective Component 1
Fire 1
Human-Device Interface Problem 1
Total Device Problems 49


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