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	137	137
Incorrect, Inadequate or Imprecise Result or Readings	91	91
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
Inaccurate Information	5	5
Sparking	4	4
Device Alarm System	3	3
Display or Visual Feedback Problem	3	3
Fire	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Intermittent Communication Failure	2	2
Material Fragmentation	2	2
Leak/Splash	2	2
No Display/Image	2	2
Low Test Results	2	2
High Readings	2	2
Ambient Temperature Problem	2	2
Battery Problem	2	2
Unable to Obtain Readings	2	2
Defective Device	2	2
Output below Specifications	2	2
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
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
Thermal Decomposition of Device	1	1
Misassembly by Users	1	1
Data Problem	1	1
Noise, Audible	1	1
Unexpected Shutdown	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	82	82
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