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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lift, patient, non-ac-powered
Regulation Description Non-AC-powered patient lift.
Product CodeFSA
Regulation Number 880.5510
Device Class 1


Premarket Reviews
ManufacturerDecision
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
TED HOYER & CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 128
Component(s), broken 118
Tipover 73
Malfunction 73
Use of Device Issue 71
Break 71
No Known Device Problem 50
Mechanical issue 45
No Information 24
Component falling 21
Detachment of device or device component 20
Unstable 16
Unknown (for use when the device problem is not known) 14
Unintended movement 13
Electrical issue 12
Material rupture 11
Component missing 11
Inadequate training 11
Fracture 10
Torn material 9
Not Applicable 9
Improper or incorrect procedure or method 9
Product quality issue 7
Accessory incompatible 7
Device maintenance issue 7
Failure to service 6
Defective component 6
Device inoperable 6
Component(s), worn 6
Defective item 6
Device Issue 6
Material separation 6
Tears, rips, holes in device, device material 6
Device operates differently than expected 5
Spark 5
Manufacturing or shipping issue associated with device 5
Battery issue 4
Size incorrect for patient 4
No code available 4
Fluid leak 4
Overheating of device or device component 3
Structural problem 3
Split 3
Maintenance does not comply to manufacturers recommendations 3
Device handling issue 3
Human-Device Interface Issue 3
Leak 3
Loose or intermittent connection 3
Misassembled 3
Disconnection 2
Burn of device or device component 2
Inadequate service 2
Misconnection 2
Material deformation 2
Material integrity issue 2
Installation-related problem 2
Misassembled by Users 2
Device emits odor 2
Component incompatible 2
Design/structure problem 2
Bacterial contamination of device 2
Other (for use when an appropriate device code cannot be identified) 2
Smoking 2
Installation error 2
Unintended arm motion 2
Collapse 2
Crack 2
Device expiration issue 1
Connector pin failure 1
Failure to charge 1
Instruction for use issue 1
Incorrect measurement 1
Difficult to flush 1
Hydrogen peroxide sterilization, explosion during 1
Slippage of device or device component 1
Nonstandard device or device component 1
Failure to auto stop 1
Inaccurate delivery 1
Fire 1
Bent 1
Material opacification 1
Hole in material 1
Fumes or vapors 1
Pressure issue 1
Misapplication 1
Contamination during use 1
Corrosion 1
Disengaged 1
Shock, electrical 1
Emergency stop button or switch failure 1
Device stops intermittently 1
Shaft break 1
Electrical shorting 1
Low battery 1
Locking mechanism failure 1
Device markings issue 1
Fail-safe mechanism issue 1
Unintended system motion 1
Material frayed 1
Total Device Problems 1014

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 6 9 6 1 4 3 3
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arjo, Inc. II Jan-30-2009
2 Arjo, Inc. II Dec-18-2008
3 Arjo, Inc. II Dec-16-2008
4 Arjo, Inc. II Nov-24-2008
5 Arjo, Inc. II Sep-30-2008
6 Arjo, Inc. II Sep-20-2008
7 Arjo, Inc. II Aug-28-2008
8 Arjo, Inc. II Aug-24-2008
9 Arjo, Inc. II Jul-30-2008
10 Arjo, Inc. II Dec-01-2007
11 Arjo, Inc. II Feb-15-2007
12 Arjo, Inc. II Jan-11-2007
13 Arjo, Inc. II Jan-11-2007
14 Arjo, Inc. dba ArjoHuntleigh II Jul-06-2012
15 Arjo, Inc. dba ArjoHuntleigh II Aug-24-2011
16 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2011
17 ArjoHuntleigh II Sep-22-2009
18 ArjoHuntleigh II Sep-08-2009
19 ArjoHuntleigh II Aug-27-2009
20 ArjoHuntleigh II Jul-24-2009
21 Hill-Rom, Inc. II Jun-05-2013
22 Hill-Rom, Inc. II Feb-21-2013
23 Hill-Rom, Inc. II Dec-31-2012
24 Hill-Rom, Inc. II Mar-17-2011
25 Hill-Rom, Inc. II Feb-23-2011
26 Joerns Healthcare Inc. II Apr-07-2007
27 KCI USA, Inc. II Apr-16-2012
28 Liko AB II Sep-20-2008
29 Liko North America Inc II Jan-27-2009
30 Molift Inc. II May-21-2013
31 Romedic, Inc. II Jun-01-2010
32 The Sisus Corporation II Aug-17-2007

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