TPLC - Total Product Life Cycle

show TPLC since

Device	unit, cryotherapy, ophthalmic
Product Code	HQA
Regulation Number	886.4170
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Temperature Problem	11	11
Leak/Splash	5	5
Excessive Cooling	5	5
Therapeutic or Diagnostic Output Failure	5	5
Pressure Problem	4	4
Material Fragmentation	4	4
Break	3	3
Defective Component	3	3
Mechanical Problem	2	2
Output Problem	2	2
Physical Resistance/Sticking	2	2
Defective Device	2	2
Structural Problem	2	2
Detachment of Device or Device Component	2	2
Suction Problem	2	2
Failure to Read Input Signal	1	1
Material Split, Cut or Torn	1	1
Device Damaged Prior to Use	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Unable to Obtain Readings	1	1
Material Twisted/Bent	1	1
Excess Flow or Over-Infusion	1	1
Infusion or Flow Problem	1	1
Material Rupture	1	1
Calibration Problem	1	1
Increase in Pressure	1	1
Appropriate Term/Code Not Available	1	1
Intermittent Continuity	1	1
Insufficient Heating	1	1
Insufficient Cooling	1	1
Flaked	1	1
Device Displays Incorrect Message	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	24	24
Insufficient Information	17	17
No Clinical Signs, Symptoms or Conditions	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1
Chemical Exposure	1	1
No Consequences Or Impact To Patient	1	1