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	157	157
Crack	89	89
Break	49	49
Fracture	15	15
Component Falling	10	10
Device Fell	10	10
Material Separation	6	6
Detachment Of Device Component	6	6
Peeled/Delaminated	5	5
Installation-Related Problem	4	4
Component Missing	3	3
Smoking	3	3
Unintended Movement	3	3
Insufficient Information	2	2
Mechanical Problem	2	2
Corroded	2	2
Fire	2	2
Migration or Expulsion of Device	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Sparking	2	2
Environmental Compatibility Problem	2	2
Flare or Flash	1	1
Operating System Becomes Nonfunctional	1	1
Temperature Problem	1	1
Material Deformation	1	1
Material Torqued	1	1
Device Issue	1	1
Device Tipped Over	1	1
Device Disinfection Or Sterilization Issue	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Fluid/Blood Leak	1	1
Electromagnetic Interference	1	1
Electrical /Electronic Property Problem	1	1
Collapse	1	1
Melted	1	1
Loose or Intermittent Connection	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Defective Component	1	1
Device Handling Problem	1	1
Noise, Audible	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	178	178
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
Bone Fracture(s)	3	3
No Information	3	3
No Code Available	2	2
Superficial (First Degree) Burn	2	2
Head Injury	2	2
Laceration(s)	2	2
Burn, Thermal	2	2
Fall	2	2
Burn(s)	1	1
Nerve Damage	1	1
Scarring	1	1