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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 118
Component(s), broken 118
Malfunction 73
Tipover 71
Break 69
Use of Device Issue 65
No Known Device Problem 45
Mechanical issue 38
No Information 23
Detachment of device or device component 16
Unknown (for use when the device problem is not known) 14
Unstable 14
Component falling 13
Electrical issue 11
Inadequate training 11
Component missing 11
Material rupture 10
Torn material 9
Improper or incorrect procedure or method 9
Unintended movement 8
Not Applicable 8
Fracture 8
Product quality issue 7
Device maintenance issue 7
Accessory incompatible 7
Failure to service 6
Device inoperable 6
Defective item 6
Device Issue 6
Tears, rips, holes in device, device material 6
Component(s), worn 6
Manufacturing or shipping issue associated with device 5
Material separation 4
Spark 4
No code available 4
Fluid leak 4
Size incorrect for patient 4
Defective component 4
Battery issue 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
Device operates differently than expected 3
Human-Device Interface Issue 3
Loose or intermittent connection 3
Misassembled 3
Disconnection 2
Burn of device or device component 2
Inadequate service 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
Material deformation 2
Material integrity issue 2
Misconnection 2
Misapplication 1
Corrosion 1
Disengaged 1
Shock, electrical 1
Emergency stop button or switch failure 1
Leak 1
Pressure issue 1
Device stops intermittently 1
Shaft break 1
Device expiration issue 1
Connector pin failure 1
Failure to charge 1
Instruction for use issue 1
Incorrect measurement 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
Material opacification 1
Hole in material 1
Fumes or vapors 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 942

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 1
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 Feb-21-2013
22 Hill-Rom, Inc. II Dec-31-2012
23 Hill-Rom, Inc. II Mar-17-2011
24 Hill-Rom, Inc. II Feb-23-2011
25 Joerns Healthcare Inc. II Apr-07-2007
26 KCI USA, Inc. II Apr-16-2012
27 Liko AB II Sep-20-2008
28 Liko North America Inc II Jan-27-2009
29 Romedic, Inc. II Jun-01-2010
30 The Sisus Corporation II Aug-17-2007

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