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
Electrical /Electronic Property Problem	6	6
Defective Component	6	6
Crack	4	4
Failure to Auto Stop	4	4
Battery Problem	4	4
Mechanical Problem	3	3
Protective Measures Problem	3	3
Patient-Device Incompatibility	3	3
Unintended Movement	3	3
Fracture	3	3
Inadequate User Interface	2	2
Intermittent Loss of Power	2	2
Device Stops Intermittently	2	2
Naturally Worn	2	2
Unintended System Motion	2	2
Nonstandard Device	2	2
Power Problem	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Device Dislodged or Dislocated	2	2
Failure to Conduct	2	2
Device Damaged by Another Device	2	2
Charging Problem	2	2
Failure to Charge	2	2
Device Maintenance Issue	2	2
Unintended Ejection	2	2
Misassembled During Installation	2	2
Patient Device Interaction Problem	2	2
Physical Resistance/Sticking	2	2
Material Integrity Problem	2	2
Fail-Safe Did Not Operate	2	2
Failure to Run on Battery	1	1
Fluid/Blood Leak	1	1
Detachment Of Device Component	1	1
Device Remains Activated	1	1
Electronic Property Issue	1	1
Device Issue	1	1
Failure to Read Input Signal	1	1
Loose or Intermittent Connection	1	1
Sparking	1	1
Device Inoperable	1	1
Failure to Shut Off	1	1
Overheating of Device	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