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
Unintended Movement	3	3
Patient-Device Incompatibility	3	3
Protective Measures Problem	3	3
Fracture	3	3
Mechanical Problem	3	3
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Failure to Conduct	2	2
Power Problem	2	2
Device Dislodged or Dislocated	2	2
Unintended System Motion	2	2
Naturally Worn	2	2
Nonstandard Device	2	2
Inadequate User Interface	2	2
Device Stops Intermittently	2	2
Intermittent Loss of Power	2	2
Material Integrity Problem	2	2
Fail-Safe Did Not Operate	2	2
Unintended Ejection	2	2
Device Maintenance Issue	2	2
Physical Resistance/Sticking	2	2
Patient Device Interaction Problem	2	2
Misassembled During Installation	2	2
Device Damaged by Another Device	2	2
Charging Problem	2	2
Failure to Charge	2	2
Failure to Run on Battery	1	1
Detachment Of Device Component	1	1
Fluid/Blood Leak	1	1
Device Inoperable	1	1
Overheating of Device	1	1
Misassembled	1	1
Material Deformation	1	1
Misassembly by Users	1	1
Solder Joint Fracture	1	1
Malposition of Device	1	1
Smoking	1	1
Off-Label Use	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