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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
Mechanical issue 352
Slippage of device or device component 299
Break 33
Unintended head motion 25
Sticking 24
Unintended movement 23
Device inoperable 18
Device operates differently than expected 17
Unintended system motion 17
No Information 15
Component missing 13
Difficult to open or close 13
Naturally worn 12
Use of Device Issue 9
Electrical issue 8
Positioning Issue 8
Detachment of device or device component 4
Mechanical jam 4
No Known Device Problem 4
Locking mechanism failure 3
Tipover 3
Human-Device Interface Issue 3
Improper or incorrect procedure or method 3
Failure to deploy 3
Detachment of device component 3
Difficult to fold or unfold 3
Component falling 3
Manufacturing or shipping issue associated with device 2
Mechanics altered 2
Fluid leak 2
Difficult to position 2
Loose 2
Device maintenance issue 2
Device handling issue 2
Bent 2
Unknown (for use when the device problem is not known) 2
Couple, failure to 1
Hydraulic system failure 1
Difficult to deploy 1
Leak(s) from hydraulic bed system 1
Misassembled 1
Foreign material 1
Fracture 1
Migration of device or device component 1
Spring loading mechanism problem 1
False claim 1
Failure to service 1
Inappropriate shock 1
Defective component 1
Solder joint failure 1
Device sensing issue 1
Electronic property issue 1
Power source issue 1
Loss of power 1
Failure to separate 1
Leak 1
Defective item 1
Calibration issue 1
Collapse 1
Crack 1
Entrapment of device or device component 1
Side rails, failure of 1
Difficult or delayed activation 1
Malposition of device 1
Total Device Problems 968

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 2 3 2 1 1 3 0 0 4 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cardiopulmonary Instrumentation, Inc II Feb-14-2012
2 Ferno-Washington Inc II Oct-01-2015
3 Ferno-Washington Inc II Aug-25-2015
4 Ferno-Washington Inc II Jan-16-2015
5 Ferno-Washington Inc II Sep-30-2008
6 Ferno-Washington Inc II Sep-11-2008
7 Hill-Rom, Inc. III Sep-16-2008
8 Sechrist Industries Inc II Jul-01-2015
9 Sechrist Industries Inc II Jan-19-2012
10 Sechrist Industries Inc II Jan-18-2008
11 Stryker Medical Div. of Stryker Corporation II Nov-08-2010
12 Stryker Medical Div. of Stryker Corporation II Nov-17-2009
13 Stryker Medical Div. of Stryker Corporation II Apr-05-2009
14 Stryker Medical Div. of Stryker Corporation II Nov-10-2007
15 Stryker Medical Div. of Stryker Corporation II Sep-21-2007
16 Stryker Medical Division of Stryker Corporation II Mar-17-2016
17 Stryker Medical Division of Stryker Corporation II Dec-19-2012
18 Stryker Medical Division of Stryker Corporation II Jul-22-2011

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