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