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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lift, patient, ac-powered
Regulation Description AC-powered patient lift.
Product CodeFNG
Regulation Number 880.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 29
Detachment of device component 20
Device Issue 18
Malfunction 16
Use of Device Issue 15
Component falling 12
Tipover 11
Detachment of device or device component 8
Break 8
User used incorrect product for intended use 6
Improper or incorrect procedure or method 5
No Known Device Problem 5
Torn material 5
Unintended movement 5
Inadequate training 4
Accessory incompatible 4
Component(s), worn 3
Mechanical issue 3
Material frayed 3
Tears, rips, holes in device, device material 3
Dissatisfaction 3
Unknown (for use when the device problem is not known) 3
Maintenance does not comply to manufacturers recommendations 3
No Information 3
Fracture 2
Defective item 2
Not Applicable 2
Other (for use when an appropriate device code cannot be identified) 2
Misapplication 2
Material rupture 2
Failure to service 2
Collapse 2
Bent 1
Component incompatible 1
Failure to deploy 1
Shaft break 1
Size incorrect for patient 1
Slippage of device or device component 1
Smoking 1
Misassembled 1
Unintended collision 1
Device inoperable 1
Tip breakage 1
Device maintenance issue 1
Device damaged prior to use 1
Semiautomatic code, failure to override 1
Component missing 1
Device Rinsing Issue 1
Inaccurate delivery 1
Arcing 1
Patient-device incompatibility 1
Buckled material 1
Device or device component damaged by another device 1
Dislodged or dislocated 1
Installation-related problem 1
No code available 1
Manufacturing or shipping issue associated with device 1
Misassembled by Users 1
Total Device Problems 237

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 1 1 0 2 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arjo, Inc. II Jul-18-2008
2 Arjo, Inc. II Jan-11-2007
3 B.H.M. Medical, Inc. II Aug-31-2009
4 Invacare Corporation II Jul-06-2011
5 Penner Mfg Inc II Apr-08-2011

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