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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 477
Detachment of device component 430
No Known Device Problem 279
Break 260
Tipover 213
Detachment of device or device component 189
Mechanical issue 189
Component(s), broken 118
Component falling 109
Unintended movement 95
Device handling issue 84
Malfunction 73
Unable to confirm conditions of use 58
Material separation 54
No Information 47
Electrical issue 46
Inadequate training 44
Device operates differently than expected 43
Improper or incorrect procedure or method 41
Maintenance does not comply to manufacturers recommendations 38
Bent 36
Installation-related problem 30
Unstable 26
Material rupture 22
Slippage of device or device component 21
Device maintenance issue 21
Crack 21
Device inoperable 20
Blockage within device or device component 19
Fracture 19
Torn material 18
Component missing 18
Device Issue 15
Not Applicable 15
Material integrity issue 14
Battery issue 14
Unknown (for use when the device problem is not known) 14
Device damaged prior to use 14
Defective component 14
Failure to service 14
Leak 14
Accessory incompatible 12
Material deformation 12
Spark 9
Material frayed 9
Product quality issue 9
Size incorrect for patient 9
Inadequate service 8
Fluid leak 8
Defective item 8
Dislodged or dislocated 7
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
Collapse 6
Misassembled by Users 6
Human-Device Interface Issue 6
Naturally worn 6
Positioning Issue 6
Split 6
Electrical shorting 6
Burn of device or device component 5
Disconnection 5
Misassembled 5
Misconnection 4
Overheating of device or device component 4
User used incorrect product for intended use 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
Shelf life exceeded 3
Device stops intermittently 3
Other (for use when an appropriate device code cannot be identified) 2
Resistance, loss of 2
Device emits odor 2
Design/structure problem 2
Material fragmentation 2
Installation error 2
Bacterial contamination of device 2
Low battery 2
Cut in material 2
Dent in material 2
Device misassembled during manufacturing or shipping 2
Device or device component damaged by another device 1
Failure to auto stop 1
Locking mechanism failure 1
Total Device Problems 3575

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 3
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 AB II Oct-11-2017
32 Handicare Accessibility II Nov-06-2013
33 Handicare Usa Inc II Sep-15-2017
34 Hill-Rom, Inc. II Oct-31-2016
35 Hill-Rom, Inc. II Jun-07-2016
36 Hill-Rom, Inc. II Jun-19-2015
37 Hill-Rom, Inc. II Jun-05-2013
38 Hill-Rom, Inc. II Feb-21-2013
39 Hill-Rom, Inc. II Dec-31-2012
40 Hill-Rom, Inc. II Mar-17-2011
41 Hill-Rom, Inc. II Feb-23-2011
42 Joerns Healthcare Inc. II Apr-07-2007
43 KCI USA, Inc. II Apr-16-2012
44 Liko AB II Sep-20-2008
45 Liko North America Inc II Jan-27-2009
46 Moller Vital II Jul-26-2016
47 Moller Vital II May-21-2013
48 Prism Medical Services USA II Jun-19-2013
49 Romedic, Inc. II Jun-01-2010
50 The Sisus Corporation II Aug-17-2007

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