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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device powered stairway chair lift
Regulation Description Powered patient transport.
Definition Intended for medical purposes to move a person with impaired mobility up and down a stairway.
Product CodePCD
Regulation Number 890.5150
Device Class 2

Device Problems
Use of Device Issue 19
Improper or incorrect procedure or method 11
Device operates differently than expected 6
Device handling issue 5
No Known Device Problem 4
No Information 3
Break 3
Inadequate user interface 2
Installation-related problem 2
Defective component 2
Crack 2
Fracture 1
Material fragmentation 1
Device maintenance issue 1
Overheating of device or device component 1
Device stops intermittently 1
Device inoperable 1
Component missing 1
Patient-device incompatibility 1
Maintenance does not comply to manufacturers recommendations 1
Material Distortion 1
Material integrity issue 1
Mechanics altered 1
Device Cleaning Issue 1
Dislodged or dislocated 1
Unintended movement 1
Misassembled by Users 1
Total Device Problems 75

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 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acorn Stairlifts Inc II Apr-20-2016

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