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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 movement 26
Unintended head motion 25
Sticking 24
Device inoperable 18
Unintended system motion 17
Device operates differently than expected 17
No Information 15
Difficult to open or close 13
Component missing 13
Naturally worn 12
Use of Device Issue 9
Electrical issue 8
Positioning Issue 8
No Known Device Problem 4
Mechanical jam 4
Detachment of device or device component 4
Tipover 3
Locking mechanism failure 3
Human-Device Interface Issue 3
Difficult to fold or unfold 3
Failure to deploy 3
Detachment of device component 3
Component falling 3
Improper or incorrect procedure or method 3
Unknown (for use when the device problem is not known) 2
Difficult to position 2
Loose 2
Device maintenance issue 2
Bent 2
Manufacturing or shipping issue associated with device 2
Mechanics altered 2
Device handling issue 2
Fluid leak 2
Power source issue 1
Electronic property issue 1
Device sensing issue 1
Malposition of device 1
Calibration issue 1
Device misassembled during manufacturing or shipping 1
Spring loading mechanism problem 1
Collapse 1
Couple, failure to 1
Crack 1
Difficult to deploy 1
Foreign material 1
Fracture 1
Entrapment of device or device component 1
False claim 1
Hydraulic system failure 1
Leak 1
Leak(s) from hydraulic bed system 1
Migration of device or device component 1
Misassembled 1
Loss of power 1
Failure to service 1
Inappropriate shock 1
Side rails, failure of 1
Defective component 1
Solder joint failure 1
Failure to separate 1
Difficult or delayed activation 1
Defective item 1
Total Device Problems 972

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 2
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 Jun-14-2016
17 Stryker Medical Division of Stryker Corporation II Mar-17-2016
18 Stryker Medical Division of Stryker Corporation II Dec-19-2012
19 Stryker Medical Division of Stryker Corporation II Jul-22-2011

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