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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

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 19 19
Adverse Event Without Identified Device or Use Problem 15 15
Improper or Incorrect Procedure or Method 10 10
Insufficient Information 7 7
Electrical /Electronic Property Problem 6 6
Mechanical Problem 4 4
Defective Component 4 4
Installation-Related Problem 4 4
Battery Problem 4 4
Failure to Charge 3 3
Failure to Conduct 3 3
Device Contaminated at the User Facility 2 2
Intermittent Loss of Power 2 2
Naturally Worn 2 2
Human-Device Interface Problem 2 2
Unintended System Motion 2 2
Power Problem 2 2
Detachment of Device or Device Component 2 2
Material Deformation 2 2
Device Damaged by Another Device 2 2
Charging Problem 2 2
Unintended Ejection 2 2
Misassembled During Installation 2 2
Patient Device Interaction Problem 2 2
Off-Label Use 2 2
Failure to Power Up 1 1
Degraded 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Fail-Safe Did Not Operate 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Unintended Movement 1 1
Intermittent Continuity 1 1
Activation Problem 1 1
Connection Problem 1 1
Incomplete or Inadequate Connection 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Device Tipped Over 1 1
Loose or Intermittent Connection 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1
Break 1 1
Failure to Read Input Signal 1 1
Loss of or Failure to Bond 1 1
Failure to Run on Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 35 35
Laceration(s) 21 21
Vertebral Fracture 13 13
Multiple Fractures 12 12
No Clinical Signs, Symptoms or Conditions 9 9
Bruise/Contusion 9 9
Hip Fracture 7 7
Skin Tears 6 6
Head Injury 5 5
Fall 5 5
Brain Injury 4 4
Abrasion 3 3
Damage to Ligament(s) 2 2
Neck Pain 2 2
Limb Fracture 2 2
Stroke/CVA 1 1
Pneumothorax 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
Perforation of Vessels 1 1
Swelling/ Edema 1 1
Unspecified Tissue Injury 1 1
Neck Stiffness 1 1

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