TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Readings	86	86
Incorrect, Inadequate or Imprecise Result or Readings	73	73
Incorrect Measurement	68	68
Failure to Analyze Signal	61	61
Patient Device Interaction Problem	47	52
Communication or Transmission Problem	45	45
Manufacturing, Packaging or Shipping Problem	39	39
Erratic or Intermittent Display	38	38
High Readings	35	35
Device Alarm System	29	29
Defective Device	28	28
Image Display Error/Artifact	27	27
Patient-Device Incompatibility	14	14
Use of Device Problem	10	10
Adverse Event Without Identified Device or Use Problem	10	11
Temperature Problem	9	9
Insufficient Information	7	7
Display or Visual Feedback Problem	7	7
Material Split, Cut or Torn	6	6
Failure to Power Up	6	6
Data Problem	4	4
Device Damaged Prior to Use	4	4
Ambient Noise Problem	2	2
Loss of or Failure to Bond	2	2
Appropriate Term/Code Not Available	2	2
Human-Device Interface Problem	2	2
Unable to Obtain Readings	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Device Fell	1	1
Display Difficult to Read	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Failure to Run on Battery	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	313	313
Insufficient Information	52	52
Pressure Sores	41	46
Unspecified Tissue Injury	13	14
Burn(s)	8	8
Superficial (First Degree) Burn	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Inflammation	3	3
Localized Skin Lesion	2	2
Skin Discoloration	2	2
Skin Tears	2	2
Low Oxygen Saturation	2	2
Stroke/CVA	1	1
Blister	1	2
Rash	1	1
Ecchymosis	1	1
Swelling/ Edema	1	1
No Consequences Or Impact To Patient	1	1
Tissue Breakdown	1	1
Bruise/Contusion	1	1