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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, obstetrical, ac-powered (and accessories)
Regulation Description Obstetric table and accessories.
Product CodeHDD
Regulation Number 884.4900
Device Class 2


Premarket Reviews
ManufacturerDecision
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended system motion 69
Slippage of device or device component 39
Locking mechanism failure 28
Unintended head motion 19
Sticking 16
Mechanical issue 14
Loose 13
Self-activation or keying 10
Grounding malfunction 8
Device operates differently than expected 4
Naturally worn 3
Device alarm system issue 3
Disengaged 3
Material disintegration 1
Displacement 1
Break 1
Device remains activated 1
Device inoperable 1
Component missing 1
Total Device Problems 235

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 1 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Dec-17-2009
2 Hill-Rom, Inc. II Apr-02-2008

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