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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, therapeutic, ac-powered, adjustable home-use
Regulation Description AC-powered adjustable hospital bed.
Product CodeLLI
Regulation Number 880.5100
Device Class 2

Device Problems
Detachment of Device or Device Component 75
Adverse Event Without Identified Device or Use Problem 26
Temperature Problem 11
Unintended Movement 11
Misassembled 5
Insufficient Information 5
Unstable 5
Use of Device Problem 4
No Apparent Adverse Event 3
Device Slipped 2
Improper or Incorrect Procedure or Method 2
Component Missing 2
Material Protrusion/Extrusion 2
Patient-Device Incompatibility 2
Separation Problem 2
Device Issue 2
Material Integrity Problem 2
Missing Value Reason 2
Break 2
Material Puncture/Hole 2
Detachment Of Device Component 2
Installation-Related Problem 2
Weld 1
Device Operates Differently Than Expected 1
Mechanical Problem 1
Misconnection 1
Component Misassembled 1
Component Falling 1
Product Quality Problem 1
Device Handling Problem 1
Patient Device Interaction Problem 1
Material Fragmentation 1
Human-Device Interface Problem 1
Material Torqued 1
Sharp Edges 1
Misassembled During Installation 1
Material Perforation 1
Total Device Problems 186

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II Feb-09-2017

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