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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
Use of Device Issue 380
Detachment of device component 357
No Known Device Problem 240
Break 228
Tipover 185
Detachment of device or device component 154
Mechanical issue 150
Component(s), broken 118
Component falling 98
Unintended movement 78
Malfunction 73
Unable to confirm conditions of use 58
Device handling issue 45
Electrical issue 45
Material separation 45
No Information 44
Device operates differently than expected 40
Improper or incorrect procedure or method 40
Maintenance does not comply to manufacturers recommendations 37
Inadequate training 32
Bent 28
Unstable 22
Material rupture 21
Slippage of device or device component 21
Device inoperable 20
Crack 20
Blockage within device or device component 19
Device maintenance issue 18
Fracture 16
Component missing 16
Installation-related problem 16
Torn material 14
Leak 14
Unknown (for use when the device problem is not known) 14
Not Applicable 13
Defective component 13
Device damaged prior to use 12
Failure to service 11
Material integrity issue 11
Accessory incompatible 10
Material frayed 9
Product quality issue 9
Material deformation 9
Device Issue 9
Spark 9
Inadequate service 8
Fluid leak 8
Component incompatible 7
Loose or intermittent connection 7
Size incorrect for patient 7
Manufacturing or shipping issue associated with device 7
Battery issue 7
Defective item 7
No code available 7
Positioning Issue 6
Solder joint failure 6
Human-Device Interface Issue 6
Tears, rips, holes in device, device material 6
Migration of device or device component 6
Component(s), worn 6
Collapse 5
Disconnection 5
Misassembled 5
Electrical shorting 5
Split 5
Naturally worn 5
Misassembled by Users 5
Mechanical jam 4
Mechanics altered 4
Structural problem 4
Failure to align 4
Fail-safe mechanism issue 4
Overheating of device or device component 4
Smoking 4
Corrosion 4
Flaked 4
Burn of device or device component 4
Unintended arm motion 4
Degraded 3
Device stops intermittently 3
Shelf life exceeded 3
User used incorrect product for intended use 3
Misconnection 3
Dislodged or dislocated 3
Out-of-box failure 3
Bacterial contamination of device 2
Cut in material 2
Dent in material 2
Arcing 2
Device emits odor 2
Resistance, loss of 2
Other (for use when an appropriate device code cannot be identified) 2
Design/structure problem 2
Material fragmentation 2
Installation error 2
Instruction for use issue 1
Hole in material 1
Hydrogen peroxide sterilization, explosion during 1
Difficult to flush 1
Disengaged 1
Total Device Problems 3047

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 6 9 6 1 4 3 6 4 3 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA SP. ZO.O. II Sep-16-2014
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Sep-24-2014
3 Arjo, Inc. II Jan-30-2009
4 Arjo, Inc. II Dec-18-2008
5 Arjo, Inc. II Dec-16-2008
6 Arjo, Inc. II Nov-24-2008
7 Arjo, Inc. II Sep-30-2008
8 Arjo, Inc. II Sep-20-2008
9 Arjo, Inc. II Aug-28-2008
10 Arjo, Inc. II Aug-24-2008
11 Arjo, Inc. II Jul-30-2008
12 Arjo, Inc. II Dec-01-2007
13 Arjo, Inc. II Feb-15-2007
14 Arjo, Inc. II Jan-11-2007
15 Arjo, Inc. II Jan-11-2007
16 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2016
17 Arjo, Inc. dba ArjoHuntleigh II Oct-17-2014
18 Arjo, Inc. dba ArjoHuntleigh II Jul-06-2012
19 Arjo, Inc. dba ArjoHuntleigh II Aug-24-2011
20 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2011
21 ArjoHuntleigh II Sep-22-2009
22 ArjoHuntleigh II Sep-08-2009
23 ArjoHuntleigh II Aug-27-2009
24 ArjoHuntleigh II Jul-24-2009
25 ErgoSafe Product LLC dba Prism Medical Services II Apr-10-2014
26 ErgoSafe Products, LLC (DBA) Prism Medical II Nov-17-2015
27 ErgoSafe Products, LLC (DBA) Prism Medical II Jul-27-2015
28 Ergosafe Products LLC DBA Prism Medical Services USA II Nov-20-2013
29 Handicare Accessibility II Nov-06-2013
30 Hill-Rom, Inc. II Jun-07-2016
31 Hill-Rom, Inc. II Jun-19-2015
32 Hill-Rom, Inc. II Jun-05-2013
33 Hill-Rom, Inc. II Feb-21-2013
34 Hill-Rom, Inc. II Dec-31-2012
35 Hill-Rom, Inc. II Mar-17-2011
36 Hill-Rom, Inc. II Feb-23-2011
37 Joerns Healthcare Inc. II Apr-07-2007
38 KCI USA, Inc. II Apr-16-2012
39 Liko AB II Sep-20-2008
40 Liko North America Inc II Jan-27-2009
41 Moller Vital II Jul-26-2016
42 Moller Vital II May-21-2013
43 Prism Medical Services USA II Jun-19-2013
44 Romedic, Inc. II Jun-01-2010
45 The Sisus Corporation II Aug-17-2007

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