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
Crack	4	4
Failure to Auto Stop	4	4
Battery Problem	4	4
Protective Measures Problem	3	3
Fracture	3	3
Mechanical Problem	3	3
Patient-Device Incompatibility	3	3
Unintended Movement	3	3
Unintended Ejection	2	2
Intermittent Loss of Power	2	2
Device Maintenance Issue	2	2
Misassembled During Installation	2	2
Device Damaged by Another Device	2	2
Charging Problem	2	2
Device Stops Intermittently	2	2
Patient Device Interaction Problem	2	2
Unintended System Motion	2	2
Naturally Worn	2	2
Failure to Charge	2	2
Inadequate User Interface	2	2
Material Integrity Problem	2	2
Physical Resistance/Sticking	2	2
Nonstandard Device	2	2
Fail-Safe Did Not Operate	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
Electronic Property Issue	1	1
Loose or Intermittent Connection	1	1
Failure to Run on Battery	1	1
Fluid/Blood Leak	1	1
Device Issue	1	1
Overheating of Device	1	1
Device Inoperable	1	1
Connection Problem	1	1
Device Reprocessing Problem	1	1
Intermittent Continuity	1	1
Human-Device Interface Problem	1	1
Complete Loss of Power	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