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