TPLC - Total Product Life Cycle

• Device: powered stairway chair lift
• Definition: Intended for medical purposes to move a person with impaired mobility up and down a stairway.
• Product Code: PCD
• Regulation Number: 890.5150
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	16	16
2015	12	12
2016	9	9
2017	12	12
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	41	41
Improper or Incorrect Procedure or Method	25	25
Adverse Event Without Identified Device or Use Problem	22	22
Installation-Related Problem	10	10
Insufficient Information	9	9
Break	9	9
Device Handling Problem	8	8
Device Operates Differently Than Expected	7	7
Electrical /Electronic Property Problem	6	6
Defective Component	6	6
Crack	4	4
Failure to Auto Stop	4	4
Patient-Device Incompatibility	3	3
Battery Problem	3	3
Protective Measures Problem	3	3
Unintended Movement	3	3
Fracture	3	3
Mechanical Problem	3	3
Device Stops Intermittently	2	2
Unintended Ejection	2	2
Nonstandard Device	2	2
Unintended System Motion	2	2
Device Maintenance Issue	2	2
Inadequate User Interface	2	2
Material Integrity Problem	2	2
Patient Device Interaction Problem	2	2
Power Problem	2	2
Physical Resistance/Sticking	2	2
Charging Problem	2	2
Device Damaged by Another Device	2	2
Device Dislodged or Dislocated	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Intermittent Loss of Power	2	2
Fail-Safe Did Not Operate	2	2
Misassembled During Installation	2	2
Misassembly During Maintenance/Repair	1	1
Incomplete or Inadequate Connection	1	1
Material Deformation	1	1
Material Distortion	1	1
Failure to Shut Off	1	1
Human Factors Issue	1	1
Human-Device Interface Problem	1	1
Electronic Property Issue	1	1
Fail-Safe Problem	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Complete Loss of Power	1	1
Component Misassembled	1	1
Mechanics Altered	1	1
Naturally Worn	1	1
Misassembly by Users	1	1
No Apparent Adverse Event	1	1
Overheating of Device	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
Fluid/Blood Leak	1	1
Degraded	1	1
Failure to Charge	1	1
Device Reprocessing Problem	1	1
Detachment Of Device Component	1	1
Intermittent Continuity	1	1
Device Inoperable	1	1
Misassembled	1	1
Material Fragmentation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Component Missing	1	1
Solder Joint Fracture	1	1
Device Issue	1	1
Failure to Advance	1	1
Sparking	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	55	55
Fall	28	28
Laceration(s)	26	26
Bruise/Contusion	17	17
No Known Impact Or Consequence To Patient	14	14
Hip Fracture	10	10
Vertebral Fracture	8	8
Injury	7	7
Multiple Fractures	6	6
No Clinical Signs, Symptoms or Conditions	6	6
Skin Tears	5	5
Abrasion	5	5
Head Injury	5	5
Death	4	4
Dementia	4	4
Brain Injury	4	4
No Consequences Or Impact To Patient	3	3
Deformity/ Disfigurement	3	3
Ambulation Difficulties	3	3
Neck Pain	2	2
Fracture, Arm	2	2
Damage to Ligament(s)	2	2
Hemorrhage, Cerebral	2	2
Paralysis	2	2
No Code Available	2	2
Balance Problems	1	1
Thrombosis/Thrombus	1	1
Localized Skin Lesion	1	1
Insufficient Information	1	1
Pneumothorax	1	1
Spinal Column Injury	1	1
Swelling	1	1
Perforation of Vessels	1	1
Concussion	1	1
Unspecified Infection	1	1
Pain	1	1
Hematoma	1	1
Syncope	1	1
Stroke/CVA	1	1
Contusion	1	1
Numbness	1	1
Loss of consciousness	1	1
Heart Failure	1	1
Neck Stiffness	1	1
Post Traumatic Wound Infection	1	1
Shaking/Tremors	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Acorn Stairlifts Inc	II	Apr-20-2016
2	Acorn Stairlifts, Inc	II	Feb-28-2022
3	Savaria Concord Lifts, Inc.	II	May-10-2017