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
Erratic or Intermittent Display	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Computer Operating System Problem	12	12
Break	11	11
Failure to Calibrate	10	10
Circuit Failure	9	9
Intermittent Loss of Power	7	7
Material Fragmentation	7	7
Use of Device Problem	7	7
Defective Component	6	6
Inadequate or Insufficient Training	5	5
Defective Device	4	4
Failure to Power Up	4	4
Component Missing	4	4
Device Handling Problem	4	4
Fitting Problem	3	3
Failure to Sense	3	3
Material Protrusion/Extrusion	3	3
Incorrect Measurement	3	3
Overheating of Device	2	2
Nonstandard Device	2	2
Inaccurate Flow Rate	2	2
Material Twisted/Bent	2	2
Unable to Obtain Readings	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device Alarm System	2	2
Output Problem	2	2
Calibration Problem	1	1
False Alarm	1	1
Misassembly During Maintenance/Repair	1	1
Detachment of Device or Device Component	1	1
Battery Problem	1	1
Patient Data Problem	1	1
Failure to Transmit Record	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Program or Algorithm Execution Failure	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Reset Problem	1	1
Inadequate User Interface	1	1
Temperature Problem	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