TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	100	100
Low Readings	91	91
Incorrect, Inadequate or Imprecise Result or Readings	78	78
Failure to Analyze Signal	63	63
Communication or Transmission Problem	45	45
Manufacturing, Packaging or Shipping Problem	39	39
Patient Device Interaction Problem	39	39
Erratic or Intermittent Display	38	38
High Readings	37	37
Device Alarm System	32	32
Image Display Error/Artifact	27	27
Defective Device	27	27
Patient-Device Incompatibility	14	14
Use of Device Problem	11	11
Temperature Problem	10	10
Insufficient Device Problem Information	7	7
Display or Visual Feedback Problem	7	7
Material Split, Cut or Torn	6	6
Failure to Power Up	6	6
Device Damaged Prior to Use	4	4
Data Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Ambient Noise Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Human-Device Interface Problem	2	2
Loss of or Failure to Bond	2	2
Mechanical Problem	1	1
Application Program Problem	1	1
Device Fell	1	1
Defective Component	1	1
Unable to Obtain Readings	1	1
No Apparent Adverse Event	1	1
Inaccurate Information	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	358	358
Insufficient Information	55	55
Pressure Sore/Ulcer	41	46
Unspecified Tissue Injury	13	14
Burn(s)	8	8
Superficial (First Degree) Burn	4	4
Appropriate Clinical Signs, Symptoms and 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