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