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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 406
Unstable 247
Detachment of device component 165
Product quality issue 127
Bent 72
Crack 49
No Known Device Problem 33
Collapse 29
Unintended movement 26
Buckled material 25
Fracture 25
Out-of-box failure 22
Component(s), broken 19
Use of Device Issue 17
Naturally worn 16
Tipover 15
Mechanical jam 14
Device operates differently than expected 13
Device inoperable 12
Detachment of device or device component 9
Material separation 8
Component falling 8
Improper or incorrect procedure or method 7
Material integrity issue 7
Unable to confirm conditions of use 6
Device Issue 6
Solder joint failure 5
Component(s), worn 5
Bolus mechanism failure 4
Device maintenance issue 4
Structural problem 4
Traditional use 4
No Information 3
Mechanical issue 3
Loose or intermittent connection 3
Difficult to fold or unfold 3
Defective component 3
Shaft break 3
Normal 2
False claim 2
Misassembled by Users 2
Maintenance does not comply to manufacturers recommendations 2
Material deformation 2
Folding Issue 2
Malfunction 1
Material Distortion 1
Device unsafe to use in environment 1
Dislodged or dislocated 1
No code available 1
Device handling issue 1
Noise, Audible 1
Mechanics altered 1
Method, improper/incorrect 1
Misapplication 1
Misassembled 1
Misconnection 1
Degraded 1
Material disintegration 1
User used incorrect product for intended use 1
Component missing 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Slippage of device or device component 1
Sticking 1
Device stops intermittently 1
Supplier 1
Failure to service 1
Inadequate service 1
Total Device Problems 1463

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 1 1 1 2 0 4 0 1 0
Class III 0 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 Nova Ortho-Med Inc II Oct-24-2016
10 Owens & Minor Distribution, Inc. II Nov-20-2014
11 Roscoe Medical Inc II Nov-12-2014

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