TPLC - Total Product Life Cycle

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Device	fluorometer, for clinical use
Regulation Description	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	629	629
Incorrect, Inadequate or Imprecise Result or Readings	182	182
Electrical /Electronic Property Problem	44	44
Failure to Align	40	40
Obstruction of Flow	30	30
High Readings	24	24
High Test Results	22	22
Fluid/Blood Leak	15	15
Infusion or Flow Problem	14	14
Noise, Audible	13	13
Leak/Splash	12	12
Mechanical Jam	12	12
Loose or Intermittent Connection	11	11
Display or Visual Feedback Problem	11	11
Temperature Problem	9	9
Low Test Results	8	8
Output Problem	8	8
Low Readings	8	8
Material Twisted/Bent	8	8
Non Reproducible Results	7	7
Computer Software Problem	6	6
Decreased Sensitivity	6	6
Suction Failure	6	6
Failure to Pump	6	6
No Flow	5	5
Priming Problem	5	5
Suction Problem	5	5
Intermittent Continuity	5	5
Electrical Power Problem	5	5
Air/Gas in Device	4	4
Break	4	4
Image Display Error/Artifact	4	4
Pressure Problem	3	3
Use of Device Problem	3	3
Communication or Transmission Problem	3	3
Patient Data Problem	3	3
Display Difficult to Read	3	3
Electrical Shorting	3	3
Detachment of Device or Device Component	3	3
Material Deformation	3	3
Complete Blockage	3	3
Data Problem	3	3
Disconnection	2	2
Device Ingredient or Reagent Problem	2	2
Intermittent Communication Failure	2	2
Deformation Due to Compressive Stress	2	2
Loss of Power	2	2
Volume Accuracy Problem	2	2
Connection Problem	2	2
Failure to Calibrate	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	972	972
No Known Impact Or Consequence To Patient	187	187
Insufficient Information	10	10
Electric Shock	1	1
Missing Value Reason	1	1