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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 458
Detachment of device component 407
No Known Device Problem 269
Break 256
Tipover 204
Detachment of device or device component 176
Mechanical issue 176
Component(s), broken 118
Component falling 107
Unintended movement 88
Malfunction 73
Device handling issue 71
Unable to confirm conditions of use 58
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 38
Bent 33
Unstable 26
Installation-related problem 23
Material rupture 22
Slippage of device or device component 21
Crack 21
Device inoperable 20
Device maintenance issue 20
Blockage within device or device component 19
Fracture 18
Torn material 17
Component missing 16
Not Applicable 15
Material integrity issue 14
Device Issue 14
Leak 14
Unknown (for use when the device problem is not known) 14
Device damaged prior to use 14
Defective component 14
Failure to service 13
Accessory incompatible 12
Material deformation 12
Battery issue 11
Spark 9
Material frayed 9
Size incorrect for patient 9
Product quality issue 9
Inadequate service 8
Fluid leak 8
Defective item 8
Solder joint failure 7
Manufacturing or shipping issue associated with device 7
No code available 7
Component incompatible 7
Loose or intermittent connection 7
Migration of device or device component 6
Tears, rips, holes in device, device material 6
Component(s), worn 6
Misassembled by Users 6
Naturally worn 6
Positioning Issue 6
Split 6
Human-Device Interface Issue 6
Dislodged or dislocated 6
Electrical shorting 6
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
Fail-safe mechanism issue 4
Structural problem 4
Failure to align 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
Bacterial contamination of device 2
Design/structure problem 2
Material fragmentation 2
Installation error 2
Other (for use when an appropriate device code cannot be identified) 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 3430

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 1
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 Feb-28-2017
27 ErgoSafe Products, LLC (DBA) Prism Medical II Dec-09-2016
28 ErgoSafe Products, LLC (DBA) Prism Medical II Nov-17-2015
29 ErgoSafe Products, LLC (DBA) Prism Medical II Jul-27-2015
30 Ergosafe Products LLC DBA Prism Medical Services USA II Nov-20-2013
31 Handicare Accessibility II Nov-06-2013
32 Hill-Rom, Inc. II Oct-31-2016
33 Hill-Rom, Inc. II Jun-07-2016
34 Hill-Rom, Inc. II Jun-19-2015
35 Hill-Rom, Inc. II Jun-05-2013
36 Hill-Rom, Inc. II Feb-21-2013
37 Hill-Rom, Inc. II Dec-31-2012
38 Hill-Rom, Inc. II Mar-17-2011
39 Hill-Rom, Inc. II Feb-23-2011
40 Joerns Healthcare Inc. II Apr-07-2007
41 KCI USA, Inc. II Apr-16-2012
42 Liko AB II Sep-20-2008
43 Liko North America Inc II Jan-27-2009
44 Moller Vital II Jul-26-2016
45 Moller Vital II May-21-2013
46 Prism Medical Services USA II Jun-19-2013
47 Romedic, Inc. II Jun-01-2010
48 The Sisus Corporation II Aug-17-2007

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