TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Volume Accuracy Problem	92	92
Device Sensing Problem	86	86
Display or Visual Feedback Problem	47	47
Component Misassembled	33	33
Computer Software Problem	32	32
Operating System Becomes Nonfunctional	24	24
Restricted Flow rate	20	20
Computer Operating System Problem	12	12
Erratic or Intermittent Display	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Break	11	11
Failure to Calibrate	10	10
Circuit Failure	9	9
Intermittent Loss of Power	7	7
Use of Device Problem	7	7
Material Fragmentation	7	7
Defective Component	6	6
Inadequate or Insufficient Training	5	5
Defective Device	4	4
Device Handling Problem	4	4
Failure to Power Up	4	4
Component Missing	4	4
Fitting Problem	3	3
Failure to Sense	3	3
Material Protrusion/Extrusion	3	3
Incorrect Measurement	3	3
Nonstandard Device	2	2
Material Twisted/Bent	2	2
Output Problem	2	2
Inaccurate Flow Rate	2	2
Unable to Obtain Readings	2	2
Overheating of Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device Alarm System	2	2
Misassembly During Maintenance/Repair	1	1
Detachment of Device or Device Component	1	1
Battery Problem	1	1
Inadequate User Interface	1	1
No Display/Image	1	1
Temperature Problem	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Failure to Transmit Record	1	1
False Alarm	1	1
Calibration Problem	1	1
Patient Data Problem	1	1
Program or Algorithm Execution Failure	1	1
Electrical /Electronic Property Problem	1	1
Reset Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	271	271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	104	104
No Known Impact Or Consequence To Patient	24	24
No Patient Involvement	15	15
No Consequences Or Impact To Patient	10	10
Insufficient Information	4	4
No Information	2	2
Cramp(s) /Muscle Spasm(s)	1	1