TPLC - Total Product Life Cycle

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Device	fluorometer, for clinical use
Product Code	KHO
Regulation Number	862.2560
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	887	941
Incorrect, Inadequate or Imprecise Result or Readings	235	249
Electrical /Electronic Property Problem	47	47
Failure to Align	44	44
Obstruction of Flow	33	33
High Readings	30	30
High Test Results	27	27
Fluid/Blood Leak	14	14
Infusion or Flow Problem	14	14
Noise, Audible	13	13
Leak/Splash	12	12
Mechanical Jam	12	12
Computer Software Problem	12	14
Display or Visual Feedback Problem	11	11
Loose or Intermittent Connection	10	10
Low Readings	10	10
Temperature Problem	9	9
Output Problem	9	9
Material Twisted/Bent	8	8
Low Test Results	7	7
Non Reproducible Results	7	7
Use of Device Problem	7	7
Electrical Power Problem	6	6
Suction Failure	6	6
Decreased Sensitivity	6	6
Failure to Pump	6	6
No Flow	5	5
Priming Problem	5	5
Suction Problem	5	5
Intermittent Continuity	5	5
Calibration Problem	5	5
Imprecision	5	5
Break	5	5
Air/Gas in Device	4	4
Device Ingredient or Reagent Problem	4	4
Communication or Transmission Problem	4	4
Image Display Error/Artifact	4	4
Complete Blockage	4	4
Pressure Problem	3	3
Patient Data Problem	3	3
Connection Problem	3	3
Display Difficult to Read	3	3
Electrical Shorting	3	3
Material Deformation	3	3
Data Problem	3	3
Detachment of Device or Device Component	3	3
Incorrect Measurement	3	3
Disconnection	2	2
Intermittent Communication Failure	2	2
Deformation Due to Compressive Stress	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	861	861
No Known Impact Or Consequence To Patient	624	680
Insufficient Information	10	10
No Consequences Or Impact To Patient	3	3
Electric Shock	1	1
Missing Value Reason	1	1