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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
No Known Device Problem 13
Detachment of device component 10
Break 7
Misassembled 3
Unintended movement 3
No Information 2
Device Issue 2
Unintended system motion 2
Unstable 2
Use of Device Issue 2
Component missing 2
Collapse 2
Kinked 2
Loose or intermittent connection 2
Device maintenance issue 2
Mechanical issue 1
Fracture 1
Solder joint failure 1
Product quality issue 1
Device inoperable 1
Misconnection 1
Detachment of device or device component 1
Device operates differently than expected 1
Material torqued 1
Device handling issue 1
Not Applicable 1
Total Device Problems 67

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 1 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GF Health Products, Inc./d.b.a.Basic American Metal Products II May-11-2012
2 Invacare Corporation II Feb-09-2017
3 Invacare Corporation II Nov-14-2011

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