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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
2018 12 12
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 20 20
Adverse Event Without Identified Device or Use Problem 17 17
Improper or Incorrect Procedure or Method 13 13
Installation-Related Problem 7 7
Insufficient Information 6 6
Electrical /Electronic Property Problem 6 6
Break 6 6
Defective Component 4 4
Failure to Auto Stop 4 4
Battery Problem 3 3
Mechanical Problem 3 3
Protective Measures Problem 3 3
Unintended Movement 2 2
Power Problem 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 2 2
Intermittent Loss of Power 2 2
Fail-Safe Did Not Operate 2 2
Misassembled During Installation 2 2
Unintended Ejection 2 2
Charging Problem 2 2
Device Damaged by Another Device 2 2
Fracture 2 2
Unintended System Motion 2 2
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
Device Maintenance Issue 1 1
Failure to Charge 1 1
Detachment Of Device Component 1 1
Intermittent Continuity 1 1
Crack 1 1
Degraded 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Failure to Shut Off 1 1
Human-Device Interface Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Fluid/Blood Leak 1 1
Misassembled 1 1
Nonstandard Device 1 1
Solder Joint Fracture 1 1
Failure to Advance 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
Misassembly During Maintenance/Repair 1 1
Incomplete or Inadequate Connection 1 1
Complete Loss of Power 1 1
Component Misassembled 1 1
No Apparent Adverse Event 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 37 37
Laceration(s) 20 20
Bruise/Contusion 13 13
Fall 12 12
Hip Fracture 9 9
Vertebral Fracture 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Multiple Fractures 6 6
No Known Impact Or Consequence To Patient 6 6
Injury 6 6
Head Injury 5 5
Skin Tears 5 5
Brain Injury 4 4
Abrasion 3 3
Death 2 2
No Consequences Or Impact To Patient 2 2
Damage to Ligament(s) 2 2
Neck Pain 2 2
Deformity/ Disfigurement 2 2
Numbness 1 1
Fracture, Arm 1 1
No Information 1 1
No Code Available 1 1
Balance Problems 1 1
Thrombosis/Thrombus 1 1
Neck Stiffness 1 1
Post Traumatic Wound Infection 1 1
Localized Skin Lesion 1 1
Insufficient Information 1 1
Pain 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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