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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, pediatric open hospital
Regulation Description Pediatric hospital bed.
Product CodeFMS
Regulation Number 880.5140
Device Class 2


Premarket Reviews
ManufacturerDecision
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K852422  MODEL 500 PEDIATRIC STRETCHER/CRIB
PEDICRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
VAIL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Sticking 5
No Information 3
Mechanical issue 2
Side rails, failure of 1
Slippage of device or device component 1
Device operates differently than expected 1
No Known Device Problem 1
Component falling 1
Fracture 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Total Device Problems 18

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 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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