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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
Detachment of device component 31
Component(s), broken 30
Detachment of device or device component 28
Use of Device Issue 26
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
Unknown (for use when the device problem is not known) 4
Maintenance does not comply to manufacturers recommendations 4
Accessory incompatible 4
Collapse 3
Component(s), worn 3
Mechanical issue 3
Tears, rips, holes in device, device material 3
Material frayed 3
Failure to service 3
Misassembled by Users 3
Dissatisfaction 3
Component missing 2
Not Applicable 2
Defective item 2
Instruction for use issue 2
Loose or intermittent connection 2
Material rupture 2
Device stops intermittently 2
Other (for use when an appropriate device code cannot be identified) 2
Device inoperable 2
Misapplication 2
Misassembled 2
Fracture 2
Corrosion 2
Bent 2
Component incompatible 1
Failure to conduct 1
Crack 1
Failure to deploy 1
Misconnection 1
Unintended collision 1
Unstable 1
Tip breakage 1
Material separation 1
Shaft break 1
Size incorrect for patient 1
Slippage of device or device component 1
Smoking 1
Positioning Issue 1
Manufacturing or shipping issue associated with device 1
Mechanical jam 1
Device damaged prior to use 1
Semiautomatic code, failure to override 1
No code available 1
Device Rinsing Issue 1
Solder joint failure 1
Inaccurate delivery 1
Split 1
Arcing 1
Patient-device incompatibility 1
Buckled material 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 400

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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