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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stretcher, wheeled
Regulation Description Wheeled stretcher.
Product CodeFPO
Regulation Number 880.6910
Device Class 2


Premarket Reviews
ManufacturerDecision
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 3
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 4
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL RETAIL SERVICES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
LUMEX
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Slippage of device or device component 287
Mechanical issue 220
Break 30
Unintended head motion 24
Sticking 21
Device inoperable 17
Unintended system motion 17
Difficult to open or close 13
Naturally worn 12
Component missing 10
Electrical issue 6
Device operates differently than expected 6
Positioning Issue 4
Human-Device Interface Issue 3
Locking mechanism failure 3
Fluid leak 2
Unknown (for use when the device problem is not known) 2
Difficult to position 2
No Information 2
Loose 2
Use of Device Issue 1
Calibration issue 1
False claim 1
Loss of power 1
Misassembled 1
Component falling 1
Tipover 1
Leak(s) from hydraulic bed system 1
Couple, failure to 1
Spring loading mechanism problem 1
Hydraulic system failure 1
Defective item 1
Collapse 1
Side rails, failure of 1
Solder joint failure 1
Bent 1
Device maintenance issue 1
Detachment of device component 1
Crack 1
Foreign material 1
Inappropriate shock 1
Total Device Problems 704

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 3 2 1 1 3 0
Class III 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardiopulmonary Instrumentation, Inc II Feb-14-2012
2 Ferno-Washington Inc II Sep-30-2008
3 Ferno-Washington Inc II Sep-11-2008
4 Hill-Rom, Inc. III Sep-16-2008
5 Sechrist Industries Inc II Jan-19-2012
6 Sechrist Industries Inc II Jan-18-2008
7 Stryker Medical Div. of Stryker Corporation II Nov-08-2010
8 Stryker Medical Div. of Stryker Corporation II Nov-17-2009
9 Stryker Medical Div. of Stryker Corporation II Apr-05-2009
10 Stryker Medical Div. of Stryker Corporation II Nov-10-2007
11 Stryker Medical Div. of Stryker Corporation II Sep-21-2007
12 Stryker Medical Division of Stryker Corporation II Dec-19-2012
13 Stryker Medical Division of Stryker Corporation II Jul-22-2011

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