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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 A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway
Product CodePCD
Regulation Number 890.5150
Device Class 2

MDR Year MDR Reports MDR Events
2021 20 20
2022 21 21
2023 21 21
2024 15 15
2025 21 21
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 22 22
Adverse Event Without Identified Device or Use Problem 17 17
Improper or Incorrect Procedure or Method 11 11
Insufficient Information 7 7
Mechanical Problem 6 6
Electrical /Electronic Property Problem 6 6
Installation-Related Problem 5 5
Defective Component 4 4
Battery Problem 4 4
Failure to Conduct 4 4
Failure to Charge 3 3
Unintended Movement 3 3
Patient Device Interaction Problem 3 3
Power Problem 3 3
Break 2 2
Off-Label Use 2 2
Device Contaminated at the User Facility 2 2
Intermittent Loss of Power 2 2
Mechanical Jam 2 2
Misassembled During Installation 2 2
Unintended Ejection 2 2
Naturally Worn 2 2
Human-Device Interface Problem 2 2
Charging Problem 2 2
Device Damaged by Another Device 2 2
Material Deformation 2 2
Unintended System Motion 2 2
Detachment of Device or Device Component 2 2
Intermittent Continuity 2 2
Component Misassembled 2 2
Fracture 2 2
Failure to Run on Battery 1 1
Loss of or Failure to Bond 1 1
Deformation Due to Compressive Stress 1 1
Loose or Intermittent Connection 1 1
Complete Loss of Power 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Mechanics Altered 1 1
Failure to Align 1 1
Failure to Power Up 1 1
Degraded 1 1
Vibration 1 1
Fail-Safe Did Not Operate 1 1
Crack 1 1
Activation Problem 1 1
Incomplete or Inadequate Connection 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 40 40
Laceration(s) 22 22
No Clinical Signs, Symptoms or Conditions 15 15
Multiple Fractures 14 14
Vertebral Fracture 14 14
Bruise/Contusion 11 11
Hip Fracture 7 7
Fall 7 7
Skin Tears 6 6
Head Injury 5 5
Brain Injury 4 4
Limb Fracture 4 4
Abrasion 3 3
Damage to Ligament(s) 2 2
Neck Pain 2 2
Stroke/CVA 1 1
Pneumothorax 1 1
Joint Dislocation 1 1
Hematoma 1 1
Localized Skin Lesion 1 1
Skin Discoloration 1 1
Paralysis 1 1
Injury 1 1
Thrombosis/Thrombus 1 1
Numbness 1 1
Insufficient Information 1 1
Balance Problems 1 1
Hyperextension 1 1
Physical Entrapment 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Neck Stiffness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acorn Stairlifts, Inc II Feb-28-2022
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