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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
2019 16 16
2020 9 9
2021 20 20
2022 21 21
2023 21 21
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Improper or Incorrect Procedure or Method 11 11
Installation-Related Problem 6 6
Electrical /Electronic Property Problem 6 6
Insufficient Information 6 6
Defective Component 4 4
Battery Problem 3 3
Mechanical Problem 3 3
Break 3 3
Protective Measures Problem 3 3
Failure to Auto Stop 3 3
Power Problem 2 2
Unintended Movement 2 2
Intermittent Loss of Power 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 2 2
Unintended Ejection 2 2
Fracture 2 2
Unintended System Motion 2 2
Device Damaged by Another Device 2 2
Charging Problem 2 2
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Solder Joint Fracture 1 1
Failure to Advance 1 1
Patient-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Misassembled 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Failure to Run on Battery 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Device Remains Activated 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Fluid/Blood Leak 1 1
Failure to Charge 1 1
Intermittent Continuity 1 1
Degraded 1 1
Complete Loss of Power 1 1
Incomplete or Inadequate Connection 1 1
Fail-Safe Did Not Operate 1 1
Misassembled During Installation 1 1
Misassembly During Maintenance/Repair 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 35 35
Laceration(s) 18 18
Bruise/Contusion 11 11
Fall 9 9
Hip Fracture 8 8
Vertebral Fracture 8 8
Multiple Fractures 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Skin Tears 5 5
Brain Injury 4 4
Injury 4 4
Head Injury 4 4
Abrasion 3 3
Death 2 2
No Consequences Or Impact To Patient 2 2
Damage to Ligament(s) 2 2
No Known Impact Or Consequence To Patient 2 2
Neck Pain 2 2
Neck Stiffness 1 1
Post Traumatic Wound Infection 1 1
Deformity/ Disfigurement 1 1
Numbness 1 1
Balance Problems 1 1
Thrombosis/Thrombus 1 1
Localized Skin Lesion 1 1
Insufficient Information 1 1
Paralysis 1 1
Pneumothorax 1 1
Perforation of Vessels 1 1
Stroke/CVA 1 1
Hematoma 1 1
Unspecified Infection 1 1

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