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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
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

MDR Year MDR Reports MDR Events
2014 16 16
2015 12 12
2016 9 9
2017 12 12
2018 12 12
2019 16 16
2020 9 9
2021 20 20
2022 21 21
2023 21 21
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 41 41
Improper or Incorrect Procedure or Method 25 25
Adverse Event Without Identified Device or Use Problem 23 23
Insufficient Information 11 11
Installation-Related Problem 10 10
Break 9 9
Device Handling Problem 8 8
Device Operates Differently Than Expected 7 7
Electrical /Electronic Property Problem 6 6
Defective Component 6 6
Battery Problem 4 4
Crack 4 4
Failure to Auto Stop 4 4
Patient-Device Incompatibility 3 3
Unintended Movement 3 3
Mechanical Problem 3 3
Fracture 3 3
Protective Measures Problem 3 3
Device Stops Intermittently 2 2
Inadequate User Interface 2 2
Failure to Charge 2 2
Unintended System Motion 2 2
Naturally Worn 2 2
Charging Problem 2 2
Device Damaged by Another Device 2 2
Nonstandard Device 2 2
Fail-Safe Did Not Operate 2 2
Material Integrity Problem 2 2
Patient Device Interaction Problem 2 2
Misassembled During Installation 2 2
Physical Resistance/Sticking 2 2
Unintended Ejection 2 2
Device Maintenance Issue 2 2
Intermittent Loss of Power 2 2
Device Dislodged or Dislocated 2 2
Power Problem 2 2
Failure to Conduct 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Overheating of Device 1 1
Device Inoperable 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1
Device Reprocessing Problem 1 1
Intermittent Continuity 1 1
Complete Loss of Power 1 1
Device Issue 1 1
Electronic Property Issue 1 1
Off-Label Use 1 1
Incomplete or Inadequate Connection 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 59 59
Laceration(s) 28 28
Fall 28 28
Bruise/Contusion 17 17
No Known Impact Or Consequence To Patient 14 14
Hip Fracture 10 10
Vertebral Fracture 8 8
Injury 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Multiple Fractures 6 6
Skin Tears 6 6
Head Injury 5 5
Abrasion 5 5
Death 4 4
Dementia 4 4
Brain Injury 4 4
Ambulation Difficulties 3 3
Deformity/ Disfigurement 3 3
No Consequences Or Impact To Patient 3 3
Damage to Ligament(s) 2 2
Fracture, Arm 2 2
No Code Available 2 2
Paralysis 2 2
Neck Pain 2 2
Hemorrhage, Cerebral 2 2
Loss of consciousness 1 1
Neck Stiffness 1 1
Shaking/Tremors 1 1
Perforation of Vessels 1 1
Hyperextension 1 1
Balance Problems 1 1
Pain 1 1
Insufficient Information 1 1
Numbness 1 1
Concussion 1 1
Swelling 1 1
Thrombosis/Thrombus 1 1
Post Traumatic Wound Infection 1 1
Spinal Column Injury 1 1
Contusion 1 1
Localized Skin Lesion 1 1
Heart Failure 1 1
Hematoma 1 1
No Information 1 1
Pneumothorax 1 1
Stroke/CVA 1 1
Syncope 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acorn Stairlifts Inc II Apr-20-2016
2 Acorn Stairlifts, Inc II Feb-28-2022
3 Savaria Concord Lifts, Inc. II May-10-2017
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