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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device walker, mechanical
Regulation Description Mechanical walker.
Product CodeITJ
Regulation Number 890.3825
Device Class 1

Device Problems
Break 400
Unstable 241
Detachment of device component 159
Product quality issue 127
Bent 70
Crack 49
No Known Device Problem 29
Unintended movement 25
Buckled material 25
Collapse 25
Fracture 24
Out-of-box failure 22
Component(s), broken 19
Naturally worn 16
Tipover 15
Use of Device Issue 15
Mechanical jam 14
Device inoperable 12
Device operates differently than expected 11
Component falling 8
Material separation 8
Improper or incorrect procedure or method 7
Unable to confirm conditions of use 6
Detachment of device or device component 5
Component(s), worn 5
Bolus mechanism failure 4
Solder joint failure 4
Structural problem 4
Traditional use 4
Defective component 3
Device Issue 3
Difficult to fold or unfold 3
Shaft break 3
Loose or intermittent connection 3
Device maintenance issue 2
False claim 2
Normal 2
Folding Issue 2
Maintenance does not comply to manufacturers recommendations 2
Misassembled by Users 2
No Information 2
Noise, Audible 1
Material deformation 1
Material Distortion 1
Material integrity issue 1
Device unsafe to use in environment 1
Mechanics altered 1
Component missing 1
Slippage of device or device component 1
Sticking 1
Device stops intermittently 1
Supplier 1
Malfunction 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Method, improper/incorrect 1
Misapplication 1
Misconnection 1
Failure to service 1
Inadequate service 1
Degraded 1
Material disintegration 1
Total Device Problems 1403

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

Recalls
Manufacturer Recall Class Date Posted
1 Briggs Medical Service Company d.b.a. Mabis II Oct-28-2014
2 Central Purchasing LLC DBA Harbor Freight Tools II Apr-10-2014
3 Essential Medical Supply, Inc. II Aug-25-2010
4 Essential Medical Supply, Inc. II Jul-20-2009
5 Etac Supply Center Ab II Jul-14-2012
6 Graham Field Atlanta II May-05-2007
7 Invacare Corporation II Jun-05-2012
8 Invacare Corporation II Sep-27-2011
9 Owens & Minor Distribution, Inc. II Nov-20-2014
10 Roscoe Medical Inc II Nov-12-2014

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