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	138	138
Incorrect, Inadequate or Imprecise Result or Readings	92	92
Smoking	13	13
Device Displays Incorrect Message	10	10
Break	8	8
Operating System Becomes Nonfunctional	7	7
Output Problem	7	7
Temperature Problem	7	7
Therapeutic or Diagnostic Output Failure	6	6
High Test Results	6	6
Electrical Power Problem	5	5
Sparking	5	5
Leak/Splash	5	5
Inaccurate Information	5	5
Application Program Freezes, Becomes Nonfunctional	3	3
Display or Visual Feedback Problem	3	3
Fire	3	3
Device Alarm System	3	3
No Display/Image	2	2
Material Fragmentation	2	2
Unable to Obtain Readings	2	2
Low Test Results	2	2
High Readings	2	2
Low Readings	2	2
Defective Device	2	2
Ambient Temperature Problem	2	2
Battery Problem	2	2
Output below Specifications	2	2
Intermittent Communication Failure	2	2
Misassembly by Users	1	1
Data Problem	1	1
Noise, Audible	1	1
Unexpected Shutdown	1	1
Power Problem	1	1
Pressure Problem	1	1
Excessive Cooling	1	1
Inappropriate or Unexpected Reset	1	1
Material Twisted/Bent	1	1
Component Missing	1	1
Failure to Advance	1	1
Failure to Transmit Record	1	1
Thermal Decomposition of Device	1	1
Device Emits Odor	1	1
Energy Output Problem	1	1
Overheating of Device	1	1
Loss of Power	1	1
Increase in Pressure	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	89	89
No Known Impact Or Consequence To Patient	78	78
No Patient Involvement	15	15
Superficial (First Degree) Burn	2	2
Alteration In Body Temperature	1	1
No Information	1	2
No Code Available	1	1
Insufficient Information	1	1
Reaction	1	1
Stroke/CVA	1	1
High Blood Pressure/ Hypertension	1	1