TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	88	88
Low Readings	74	74
Incorrect Measurement	60	60
Patient Device Interaction Problem	47	47
Erratic or Intermittent Display	37	37
High Readings	35	35
Failure to Analyze Signal	35	35
Device Alarm System	24	24
Patient-Device Incompatibility	14	14
Adverse Event Without Identified Device or Use Problem	12	12
Image Display Error/Artifact	9	9
Use of Device Problem	8	8
Display or Visual Feedback Problem	8	8
Insufficient Information	7	7
Temperature Problem	7	7
Failure to Power Up	6	6
Loss of or Failure to Bond	6	6
Communication or Transmission Problem	4	4
Data Problem	4	4
Output Problem	3	3
Device Damaged Prior to Use	3	3
Detachment of Device or Device Component	3	3
Appropriate Term/Code Not Available	3	3
Defective Component	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Ambient Noise Problem	2	2
Device Slipped	1	1
Failure to Shut Off	1	1
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Device Fell	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination /Decontamination Problem	1	1
Unable to Obtain Readings	1	1
No Apparent Adverse Event	1	1
Human-Device Interface Problem	1	1
Loose or Intermittent Connection	1	1
Failure to Run on Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	215	215
Pressure Sores	43	43
No Consequences Or Impact To Patient	36	36
Insufficient Information	35	35
Unspecified Tissue Injury	12	12
Burn(s)	10	10
No Known Impact Or Consequence To Patient	8	8
No Information	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Patient Involvement	4	4
Inflammation	3	3
Localized Skin Lesion	2	2
Skin Tears	2	2
Low Oxygen Saturation	2	2
Superficial (First Degree) Burn	1	1
Stroke/CVA	1	1
Death	1	1
Skin Irritation	1	1
Blister	1	1
Skin Discoloration	1	1
Rash	1	1
Ecchymosis	1	1
Tissue Breakdown	1	1
Bruise/Contusion	1	1