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
Component Falling	10	10
Device Fell	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
Adverse Event Without Identified Device or Use Problem	2	2
Mechanical Problem	2	2
Fire	2	2
Migration or Expulsion of Device	2	2
Fluid/Blood Leak	1	1
Temperature Problem	1	1
Noise, Audible	1	1
Material Torqued	1	1
Device Operates Differently Than Expected	1	1
Defective Component	1	1
Collapse	1	1
Device Tipped Over	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Device Issue	1	1
Electromagnetic Interference	1	1
Melted	1	1
Device Disinfection Or Sterilization Issue	1	1
No Apparent Adverse Event	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Use of Device Problem	1	1
Flare or Flash	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