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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

Device Problems
Use of Device Problem 373
Detachment Of Device Component 296
Break 251
Detachment of Device or device Component 209
Adverse Event Without Identified Device or Use Problem 207
Device Tipped Over 129
Mechanical Problem 103
Unintended Movement 102
Device Handling Problem 87
Component Falling 73
Installation-Related Problem 38
Inadequate or Insufficient Training 36
Material Separation 29
Bent 29
Device Fell 27
Fracture 26
Human Factors Issue 25
Material Rupture 24
Improper or Incorrect Procedure or Method 23
Unstable 22
Device Operates Differently Than Expected 22
Maintenance Does Not Comply To Manufacturers Recommendations 18
Insufficient Information 18
Material Integrity Problem 16
Material Split, Cut or Torn 15
Device Issue 12
Material Deformation 12
Device Dislodged or Dislocated 11
Electrical /Electronic Property Problem 10
Battery Problem 10
Device Inoperable 10
Actuator 10
Device Maintenance Issue 10
Crack 10
Leak / Splash 9
Torn Material 8
Device Operational Issue 8
Device Component Or Accessory 8
Material Frayed 8
Caster 8
Component Missing 7
Defective Component 7
Solder Joint Fracture 7
Partial Blockage 7
Off-Label Use 6
Unclear Information 6
Device Slipped 6
Failure To Service 6
Inadequate Service 6
Failure to Align 5
Material Fragmentation 5
Mechanical Jam 5
Inadequacy of Device Shape and/or Size 5
Electrical Shorting 4
Collapse 4
Naturally Worn 4
Mechanics Altered 4
Flaked 4
Loose or Intermittent Connection 4
Fail-Safe Problem 4
No Apparent Adverse Event 4
Fail-Safe Did Not Operate 4
Human-Device Interface Problem 4
Material Twisted / Bent 4
Bolt 3
Corroded 3
Frame 3
Smoking 3
None 3
Misassembled 3
Thermal Decomposition of Device 3
Disconnection 3
Positioning Problem 3
Switch, Push Button 3
Device Damaged Prior to Use 3
Shelf Life Exceeded 3
Cut In Material 3
Defective Device 3
Accessory Incompatible 3
Out-Of-Box Failure 3
Component Incompatible 3
Positioning Failure 3
Clip 2
Wheel 2
Misassembly by Users 2
Motor 2
Dent in Material 2
Unintended Arm Motion 2
Fluid Leak 2
Noise, Audible 2
Unintended System Motion 2
Weld 2
Appropriate Term/Code Not Available 2
Structural Problem 2
Resistance, loss of 2
Misconnection 2
Product Quality Problem 2
Misassembled During Installation 2
Sparking 2
Fire 1
Total Device Problems 2553

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA SP. ZO.O. II Sep-16-2014
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Dec-07-2018
3 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Sep-24-2014
4 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2016
5 Arjo, Inc. dba ArjoHuntleigh II Oct-17-2014
6 Arjohuntleigh Magog II Aug-07-2018
7 Autochair II Apr-18-2018
8 ErgoSafe Product LLC dba Prism Medical Services II Apr-10-2014
9 ErgoSafe Products, LLC (DBA) Prism Medical II Feb-28-2017
10 ErgoSafe Products, LLC (DBA) Prism Medical II Dec-09-2016
11 ErgoSafe Products, LLC (DBA) Prism Medical II Nov-17-2015
12 ErgoSafe Products, LLC (DBA) Prism Medical II Jul-27-2015
13 Handicare AB II Oct-11-2017
14 Handicare Usa Inc II Sep-15-2017
15 Hill-Rom, Inc. II Oct-31-2016
16 Hill-Rom, Inc. II Jun-07-2016
17 Hill-Rom, Inc. II Jun-19-2015
18 Invacare Corporation II Dec-03-2018
19 Liko AB II Oct-12-2018
20 Moller Vital II May-16-2019
21 Moller Vital II Jul-26-2016

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