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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 30
Detachment of device component 29
Detachment of device or device component 27
Use of Device Issue 25
Inadequate training 20
Tipover 19
Device Issue 18
No Known Device Problem 17
Malfunction 16
Break 16
Electrical issue 16
Component falling 15
Device handling issue 12
Unable to confirm conditions of use 8
Unintended movement 7
User used incorrect product for intended use 7
Improper or incorrect procedure or method 5
Device maintenance issue 5
No Information 5
Torn material 5
Maintenance does not comply to manufacturers recommendations 4
Unknown (for use when the device problem is not known) 4
Accessory incompatible 4
Collapse 3
Material frayed 3
Component(s), worn 3
Mechanical issue 3
Failure to service 3
Tears, rips, holes in device, device material 3
Dissatisfaction 3
Misassembled by Users 3
Not Applicable 2
Component missing 2
Device stops intermittently 2
Defective item 2
Material rupture 2
Other (for use when an appropriate device code cannot be identified) 2
Device inoperable 2
Misapplication 2
Misassembled 2
Instruction for use issue 2
Loose or intermittent connection 2
Fracture 2
Bent 2
Component incompatible 1
Failure to conduct 1
Corrosion 1
Crack 1
Failure to deploy 1
Misconnection 1
Unintended collision 1
Shaft break 1
Size incorrect for patient 1
Slippage of device or device component 1
Smoking 1
Unstable 1
Material separation 1
Tip breakage 1
Device damaged prior to use 1
Semiautomatic code, failure to override 1
Patient-device incompatibility 1
Buckled material 1
Device Rinsing Issue 1
Solder joint failure 1
Inaccurate delivery 1
Split 1
Arcing 1
No code available 1
Manufacturing or shipping issue associated with device 1
Mechanical jam 1
Positioning Issue 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Dislodged or dislocated 1
Installation-related problem 1
Total Device Problems 395

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 1 1 0 2 0 1 0 0 0 0
Class III 0 0 0 0 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
6 Prism Medical Services USA II Jun-21-2013

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