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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
2020 9 9
2021 20 20
2022 21 21
2023 21 21
2024 15 15
2025 21 21
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 23 23
Adverse Event Without Identified Device or Use Problem 17 17
Improper or Incorrect Procedure or Method 14 14
Insufficient Device Problem Information 10 10
Mechanical Problem 6 6
Electrical /Electronic Property Problem 6 6
Installation-Related Problem 5 5
Fracture 5 5
Patient Device Interaction Problem 5 5
Failure to Conduct 4 4
Unintended Movement 4 4
Battery Problem 4 4
Failure to Charge 3 3
Break 3 3
Power Problem 3 3
Defective Component 3 3
Detachment of Device or Device Component 2 2
Component Misassembled 2 2
Material Deformation 2 2
Device Damaged by Another Device 2 2
Charging Problem 2 2
Intermittent Continuity 2 2
Unintended System Motion 2 2
Unintended Ejection 2 2
Misassembled During Installation 2 2
Human-Device Interface Problem 2 2
Naturally Worn 2 2
Mechanical Jam 2 2
Intermittent Loss of Power 2 2
Device Contaminated at the User Facility 2 2
Physical Resistance/Sticking 2 2
Off-Label Use 2 2
Circuit Failure 2 2
Connection Problem 1 1
Complete Loss of Power 1 1
Loose or Intermittent Connection 1 1
Deformation Due to Compressive Stress 1 1
Device Dislodged or Dislocated 1 1
Failure to Advance 1 1
Loss of or Failure to Bond 1 1
Failure to Run on Battery 1 1
No Apparent Adverse Event 1 1
Inadequacy of Device Shape and/or Size 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Handling Problem 1 1
Misassembled 1 1
Misassembly During Maintenance/Repair 1 1
Mechanics Altered 1 1
Failure to Align 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 43 43
Laceration(s) 25 25
No Clinical Signs, Symptoms or Conditions 18 18
Multiple Fractures 16 16
Vertebral Fracture 15 15
Bruise/Contusion 13 13
Fall 11 11
Hip Fracture 8 8
Skin Tears 6 6
Head Injury 5 5
Limb Fracture 5 5
Brain Injury 4 4
Abrasion 3 3
Damage to Ligament(s) 2 2
Injury 2 2
Neck Pain 2 2
Stroke/CVA 1 1
Death 1 1
Pneumothorax 1 1
Joint Dislocation 1 1
Hematoma 1 1
Localized Skin Lesion 1 1
Skin Discoloration 1 1
No Known Impact Or Consequence To Patient 1 1
Back pain 1 1
Intracranial Hemorrhage 1 1
Paralysis 1 1
Thrombosis/Thrombus 1 1
Numbness 1 1
Insufficient Information 1 1
Balance Problems 1 1
Hyperextension 1 1
Physical Entrapment 1 1
Limb Pain 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Neck Stiffness 1 1
Deformity/ Disfigurement 1 1

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