TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Volume Accuracy Problem	90	90
Device Sensing Problem	84	84
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
Break	11	11
Failure to Calibrate	10	10
Computer Operating System Problem	8	8
Circuit Failure	8	8
Material Fragmentation	7	7
Use of Device Problem	7	7
Intermittent Loss of Power	7	7
Defective Component	6	6
Inadequate or Insufficient Training	5	5
Component Missing	4	4
Defective Device	4	4
Failure to Power Up	4	4
Device Handling Problem	4	4
Material Protrusion/Extrusion	3	3
Incorrect Measurement	3	3
Fitting Problem	3	3
Failure to Sense	3	3
Nonstandard Device	2	2
Overheating of Device	2	2
Unable to Obtain Readings	2	2
Inaccurate Flow Rate	2	2
Device Alarm System	2	2
Material Twisted/Bent	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
Reset Problem	1	1
Temperature Problem	1	1
Appropriate Term/Code Not Available	1	1
Patient Data Problem	1	1
Program or Algorithm Execution Failure	1	1
Misassembly During Maintenance/Repair	1	1
False Alarm	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Failure to Transmit Record	1	1
Battery Problem	1	1
Calibration Problem	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	264	264
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	102	102
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