TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
KINETIC INNOVATIVE SEATING SYSTEM, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	7	7
Appropriate Term/Code Not Available	6	6
Degraded	3	3
Use of Device Problem	2	2
Nonstandard Device	2	2
Self-Activation or Keying	2	2
Improper or Incorrect Procedure or Method	2	2
Fluid/Blood Leak	2	2
Failure to Read Input Signal	1	1
Activation, Positioning or Separation Problem	1	1
Unexpected Shutdown	1	1
Break	1	1
Off-Label Use	1	1
Material Puncture/Hole	1	1
Unintended Movement	1	1
Fail-Safe Did Not Operate	1	1
Key or Button Unresponsive/not Working	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Rupture	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Installation-Related Problem	1	1
Explosion	1	1
Gel Leak	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	18	18
No Clinical Signs, Symptoms or Conditions	5	5
Fall	5	5
Insufficient Information	2	2
Bone Fracture(s)	1	1
Multiple Fractures	1	1
Intracranial Hemorrhage	1	1
Concussion	1	1
Ulcer	1	1
Spinal Cord Injury	1	1