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
Battery Problem	4	4
Failure to Auto Stop	4	4
Crack	4	4
Protective Measures Problem	3	3
Fracture	3	3
Unintended Movement	3	3
Patient-Device Incompatibility	3	3
Mechanical Problem	3	3
Charging Problem	2	2
Device Damaged by Another Device	2	2
Material Integrity Problem	2	2
Fail-Safe Did Not Operate	2	2
Nonstandard Device	2	2
Naturally Worn	2	2
Unintended System Motion	2	2
Physical Resistance/Sticking	2	2
Failure to Charge	2	2
Inadequate User Interface	2	2
Intermittent Loss of Power	2	2
Device Stops Intermittently	2	2
Patient Device Interaction Problem	2	2
Misassembled During Installation	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Device Dislodged or Dislocated	2	2
Failure to Conduct	2	2
Power Problem	2	2
Device Maintenance Issue	2	2
Unintended Ejection	2	2
Human-Device Interface Problem	1	1
Connection Problem	1	1
Intermittent Continuity	1	1
Detachment Of Device Component	1	1
Complete Loss of Power	1	1
Failure to Run on Battery	1	1
Fluid/Blood Leak	1	1
Device Reprocessing Problem	1	1
Solder Joint Fracture	1	1
Material Deformation	1	1
Misassembled	1	1
Component Missing	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
Skin Tears	6	6
No Clinical Signs, Symptoms or Conditions	6	6
Multiple Fractures	6	6
Head Injury	5	5
Abrasion	5	5
Death	4	4
Dementia	4	4
Brain Injury	4	4
Ambulation Difficulties	3	3
No Consequences Or Impact To Patient	3	3
Deformity/ Disfigurement	3	3
Hemorrhage, Cerebral	2	2
Neck Pain	2	2
Paralysis	2	2
No Code Available	2	2
Damage to Ligament(s)	2	2
Fracture, Arm	2	2
Post Traumatic Wound Infection	1	1
Spinal Column Injury	1	1
Contusion	1	1
Thrombosis/Thrombus	1	1
Localized Skin Lesion	1	1
Swelling	1	1
Concussion	1	1
Numbness	1	1
Insufficient Information	1	1
Hematoma	1	1
Heart Failure	1	1
No Information	1	1
Pain	1	1
Balance Problems	1	1
Hyperextension	1	1
Shaking/Tremors	1	1
Perforation of Vessels	1	1
Neck Stiffness	1	1
Pneumothorax	1	1
Loss of consciousness	1	1
Stroke/CVA	1	1
Syncope	1	1
Unspecified Infection	1	1