TPLC - Total Product Life Cycle

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Device	computer, diagnostic, pre-programmed, single-function
Product Code	DXG
Regulation Number	870.1435
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	139	139
Incorrect, Inadequate or Imprecise Result or Readings	95	95
Smoking	13	13
Device Displays Incorrect Message	10	10
Break	9	9
Output Problem	8	8
Leak/Splash	7	7
Operating System Becomes Nonfunctional	7	7
Temperature Problem	7	7
Therapeutic or Diagnostic Output Failure	6	6
High Test Results	6	6
Inaccurate Information	5	5
Sparking	5	5
Electrical Power Problem	5	5
Fire	3	3
Battery Problem	3	3
Device Alarm System	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Display or Visual Feedback Problem	3	3
Low Readings	2	2
Ambient Temperature Problem	2	2
High Readings	2	2
Output below Specifications	2	2
Fluid/Blood Leak	2	2
Low Test Results	2	2
Intermittent Communication Failure	2	2
Material Fragmentation	2	2
Unable to Obtain Readings	2	2
Defective Device	2	2
No Display/Image	2	2
Power Problem	1	1
Overheating of Device	1	1
Inappropriate or Unexpected Reset	1	1
Increase in Pressure	1	1
Excessive Heating	1	1
Failure to Advance	1	1
Loss of Power	1	1
Noise, Audible	1	1
Misassembly by Users	1	1
Data Problem	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Energy Output Problem	1	1
Failure to Transmit Record	1	1
Thermal Decomposition of Device	1	1
Excessive Cooling	1	1
Material Separation	1	1
Unexpected Shutdown	1	1
Device Emits Odor	1	1
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	119	119
No Clinical Signs, Symptoms or Conditions	99	99
No Known Impact Or Consequence To Patient	78	78
No Patient Involvement	15	15
Superficial (First Degree) Burn	2	2
Insufficient Information	2	2
High Blood Pressure/ Hypertension	1	1
Stroke/CVA	1	1
No Code Available	1	1
No Information	1	2
Alteration In Body Temperature	1	1
Reaction	1	1