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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 414
Detachment of device component 376
No Known Device Problem 256
Break 239
Tipover 194
Mechanical issue 173
Detachment of device or device component 160
Component(s), broken 118
Component falling 101
Unintended movement 82
Malfunction 73
Unable to confirm conditions of use 58
Device handling issue 54
Material separation 52
No Information 47
Electrical issue 46
Device operates differently than expected 42
Improper or incorrect procedure or method 41
Maintenance does not comply to manufacturers recommendations 38
Inadequate training 35
Bent 30
Unstable 25
Material rupture 22
Slippage of device or device component 21
Device inoperable 20
Crack 20
Blockage within device or device component 19
Device maintenance issue 19
Fracture 17
Installation-related problem 17
Component missing 16
Torn material 16
Not Applicable 15
Material integrity issue 14
Defective component 14
Leak 14
Unknown (for use when the device problem is not known) 14
Device damaged prior to use 13
Failure to service 13
Accessory incompatible 11
Material deformation 11
Device Issue 10
Spark 9
Material frayed 9
Product quality issue 9
Inadequate service 8
Fluid leak 8
Battery issue 8
Defective item 7
Solder joint failure 7
No code available 7
Manufacturing or shipping issue associated with device 7
Component incompatible 7
Loose or intermittent connection 7
Size incorrect for patient 7
Tears, rips, holes in device, device material 6
Migration of device or device component 6
Component(s), worn 6
Positioning Issue 6
Naturally worn 6
Misassembled by Users 6
Human-Device Interface Issue 6
Electrical shorting 6
Dislodged or dislocated 5
Split 5
Collapse 5
Burn of device or device component 5
Disconnection 5
Misassembled 5
Misconnection 4
Overheating of device or device component 4
Smoking 4
Corrosion 4
Flaked 4
Unintended arm motion 4
Structural problem 4
Failure to align 4
Fail-safe mechanism issue 4
Mechanical jam 4
Mechanics altered 4
Arcing 3
Out-of-box failure 3
Degraded 3
Device stops intermittently 3
Shelf life exceeded 3
User used incorrect product for intended use 3
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
Bacterial contamination of device 2
Cut in material 2
Low battery 2
Dent in material 2
Device misassembled during manufacturing or shipping 2
Device markings issue 1
Connection issue 1
Locking mechanism failure 1
Total Device Problems 3235

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 6 9 6 1 4 3 6 4 3 5 0
Class III 0 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 Dec-09-2016
27 ErgoSafe Products, LLC (DBA) Prism Medical II Nov-17-2015
28 ErgoSafe Products, LLC (DBA) Prism Medical II Jul-27-2015
29 Ergosafe Products LLC DBA Prism Medical Services USA II Nov-20-2013
30 Handicare Accessibility II Nov-06-2013
31 Hill-Rom, Inc. II Oct-31-2016
32 Hill-Rom, Inc. II Jun-07-2016
33 Hill-Rom, Inc. II Jun-19-2015
34 Hill-Rom, Inc. II Jun-05-2013
35 Hill-Rom, Inc. II Feb-21-2013
36 Hill-Rom, Inc. II Dec-31-2012
37 Hill-Rom, Inc. II Mar-17-2011
38 Hill-Rom, Inc. II Feb-23-2011
39 Joerns Healthcare Inc. II Apr-07-2007
40 KCI USA, Inc. II Apr-16-2012
41 Liko AB II Sep-20-2008
42 Liko North America Inc II Jan-27-2009
43 Moller Vital II Jul-26-2016
44 Moller Vital II May-21-2013
45 Prism Medical Services USA II Jun-19-2013
46 Romedic, Inc. II Jun-01-2010
47 The Sisus Corporation II Aug-17-2007

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