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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 24
Inadequate training 20
Device Issue 18
Tipover 18
Electrical issue 16
No Known Device Problem 16
Break 16
Malfunction 16
Component falling 15
Device handling issue 12
Unable to confirm conditions of use 8
User used incorrect product for intended use 7
Unintended movement 7
Device maintenance issue 5
Torn material 5
No Information 5
Improper or incorrect procedure or method 5
Maintenance does not comply to manufacturers recommendations 4
Unknown (for use when the device problem is not known) 4
Accessory incompatible 4
Dissatisfaction 3
Misassembled by Users 3
Collapse 3
Mechanical issue 3
Component(s), worn 3
Material frayed 3
Failure to service 3
Tears, rips, holes in device, device material 3
Bent 2
Fracture 2
Device stops intermittently 2
Device inoperable 2
Misassembled 2
Component missing 2
Not Applicable 2
Loose or intermittent connection 2
Material rupture 2
Other (for use when an appropriate device code cannot be identified) 2
Defective item 2
Misapplication 2
Unintended collision 1
Shaft break 1
Size incorrect for patient 1
Arcing 1
Device or device component damaged by another device 1
Installation-related problem 1
Mechanical jam 1
Material separation 1
Component incompatible 1
Failure to deploy 1
Inaccurate delivery 1
Split 1
Slippage of device or device component 1
Crack 1
Instruction for use issue 1
Device damaged prior to use 1
Device Rinsing Issue 1
Manufacturing or shipping issue associated with device 1
Positioning Issue 1
Failure to conduct 1
No code available 1
Buckled material 1
Dislodged or dislocated 1
Smoking 1
Semiautomatic code, failure to override 1
Unstable 1
Solder joint failure 1
Tip breakage 1
Corrosion 1
Misconnection 1
Patient-device incompatibility 1
Device operates differently than expected 1
Total Device Problems 391

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 1 1 0 2 0 1 0 0 0
Class III 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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