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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


Premarket Reviews
ManufacturerDecision
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 7
Use of Device Issue 4
No Known Device Problem 2
Unintended movement 1
No Information 1
Defective component 1
Defective item 1
Break 1
Collapse 1
Detachment of device component 1
Misapplication 1
Total Device Problems 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom Manufacturing, Inc. II Aug-25-2009
2 Hill-Rom, Inc. III Mar-01-2012

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