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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, manual
Regulation Description Manual adjustable hospital bed.
Product CodeFNJ
Regulation Number 880.5120
Device Class 1


Premarket Reviews
ManufacturerDecision
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K823821  SIDE RAIL PADS
  2.  K892877  CRADLE, HOSPITAL BED CLOTHING
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENOX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKIL CARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Entrapment of device or device component 4
Component(s), broken 3
Other (for use when an appropriate device code cannot be identified) 3
Side rails, failure of 3
Slippage of device or device component 3
No Known Device Problem 2
Locking mechanism failure 2
Device abrasion from instrument or another object 2
Prep, failure to 1
Product quality issue 1
Replace 1
Detachment of device or device component 1
Dislodged or dislocated 1
Detachment of device component 1
Design/structure problem 1
Displacement 1
Fire 1
Fracture 1
Installation error 1
Use of Device Issue 1
Total Device Problems 34

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 2 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 Aug-03-2010
2 Stryker Medical Div. of Stryker Corporation II Sep-01-2010

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