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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 402
Unstable 244
Detachment of device component 162
Product quality issue 127
Bent 72
Crack 49
No Known Device Problem 33
Collapse 28
Fracture 25
Unintended movement 25
Buckled material 25
Out-of-box failure 22
Component(s), broken 19
Use of Device Issue 16
Naturally worn 16
Tipover 15
Mechanical jam 14
Device operates differently than expected 13
Device inoperable 12
Material separation 8
Component falling 8
Improper or incorrect procedure or method 7
Detachment of device or device component 6
Unable to confirm conditions of use 6
Component(s), worn 5
Bolus mechanism failure 4
Structural problem 4
Traditional use 4
Solder joint failure 4
Device Issue 4
Defective component 3
Material integrity issue 3
No Information 3
Loose or intermittent connection 3
Device maintenance issue 3
Difficult to fold or unfold 3
Shaft break 3
False claim 2
Normal 2
Misassembled by Users 2
Component missing 2
Folding Issue 2
Maintenance does not comply to manufacturers recommendations 2
Material deformation 2
Material Distortion 1
Device unsafe to use in environment 1
Malfunction 1
No code available 1
Noise, Audible 1
Mechanics altered 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
Mechanical issue 1
Method, improper/incorrect 1
Misapplication 1
Misassembled 1
Misconnection 1
Degraded 1
Material disintegration 1
Total Device Problems 1435

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 1
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 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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