TPLC - Total Product Life Cycle

show TPLC since

Device	device, medical examination, ac powered
Product Code	KZF
Regulation Number	880.6320
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	159	159
Crack	90	90
Break	49	49
Fracture	15	15
Device Fell	10	10
Component Falling	10	10
Detachment Of Device Component	6	6
Material Separation	6	6
Peeled/Delaminated	5	5
Component Missing	4	4
Installation-Related Problem	4	4
Sparking	3	3
Smoking	3	3
Unintended Movement	3	3
Material Split, Cut or Torn	2	2
Environmental Compatibility Problem	2	2
Insufficient Information	2	2
Corroded	2	2
Migration or Expulsion of Device	2	2
Fire	2	2
Mechanical Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	1	1
Material Deformation	1	1
Use of Device Problem	1	1
Flare or Flash	1	1
Collapse	1	1
Device Operates Differently Than Expected	1	1
Device Disinfection Or Sterilization Issue	1	1
No Apparent Adverse Event	1	1
Device Tipped Over	1	1
Noise, Audible	1	1
Temperature Problem	1	1
Fluid/Blood Leak	1	1
Loose or Intermittent Connection	1	1
Device Issue	1	1
Improper or Incorrect Procedure or Method	1	1
Electrical /Electronic Property Problem	1	1
Material Torqued	1	1
Electromagnetic Interference	1	1
Melted	1	1
Defective Component	1	1
Device-Device Incompatibility	1	1
Fitting Problem	1	1
Operating System Becomes Nonfunctional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	183	183
No Patient Involvement	46	46
No Consequences Or Impact To Patient	29	29
No Known Impact Or Consequence To Patient	25	25
Injury	4	4
Laceration(s)	4	4
No Information	3	3
Bone Fracture(s)	3	3
Superficial (First Degree) Burn	2	2
No Code Available	2	2
Head Injury	2	2
Burn, Thermal	2	2
Fall	2	2
Scarring	1	1
Burn(s)	1	1
Nerve Damage	1	1
Cancer	1	1