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 Code	PCD
Regulation Number	890.5150
Device Class	2

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	23	23
Insufficient Information	11	11
Installation-Related Problem	10	10
Break	9	9
Device Handling Problem	8	8
Device Operates Differently Than Expected	7	7
Defective Component	6	6
Electrical /Electronic Property Problem	6	6
Failure to Auto Stop	4	4
Crack	4	4
Battery Problem	4	4
Protective Measures Problem	3	3
Patient-Device Incompatibility	3	3
Unintended Movement	3	3
Fracture	3	3
Mechanical Problem	3	3
Naturally Worn	2	2
Nonstandard Device	2	2
Unintended System Motion	2	2
Device Dislodged or Dislocated	2	2
Failure to Conduct	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Power Problem	2	2
Intermittent Loss of Power	2	2
Device Maintenance Issue	2	2
Unintended Ejection	2	2
Physical Resistance/Sticking	2	2
Misassembled During Installation	2	2
Patient Device Interaction Problem	2	2
Device Damaged by Another Device	2	2
Inadequate User Interface	2	2
Charging Problem	2	2
Device Stops Intermittently	2	2
Material Integrity Problem	2	2
Fail-Safe Did Not Operate	2	2
Failure to Charge	2	2
Incomplete or Inadequate Connection	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Loose or Intermittent Connection	1	1
Mechanics Altered	1	1
Device Issue	1	1
Misassembly During Maintenance/Repair	1	1
Electronic Property Issue	1	1
Component Misassembled	1	1
Detachment of Device or Device Component	1	1
Labelling, Instructions for Use or Training Problem	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	59	59
Laceration(s)	28	28
Fall	28	28
Bruise/Contusion	17	17
No Known Impact Or Consequence To Patient	14	14
Hip Fracture	10	10
Vertebral Fracture	8	8
Injury	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Multiple Fractures	6	6
Skin Tears	6	6
Head Injury	5	5
Abrasion	5	5
Death	4	4
Dementia	4	4
Brain Injury	4	4
Ambulation Difficulties	3	3
Deformity/ Disfigurement	3	3
No Consequences Or Impact To Patient	3	3
Damage to Ligament(s)	2	2
Fracture, Arm	2	2
No Code Available	2	2
Paralysis	2	2
Neck Pain	2	2
Hemorrhage, Cerebral	2	2
Loss of consciousness	1	1
Neck Stiffness	1	1
Shaking/Tremors	1	1
Perforation of Vessels	1	1
Hyperextension	1	1
Balance Problems	1	1
Pain	1	1
Insufficient Information	1	1
Numbness	1	1
Concussion	1	1
Swelling	1	1
Thrombosis/Thrombus	1	1
Post Traumatic Wound Infection	1	1
Spinal Column Injury	1	1
Contusion	1	1
Localized Skin Lesion	1	1
Heart Failure	1	1
Hematoma	1	1
No Information	1	1
Pneumothorax	1	1
Stroke/CVA	1	1
Syncope	1	1
Unspecified Infection	1	1