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	594	594
Incorrect, Inadequate or Imprecise Result or Readings	192	192
Failure to Align	40	40
Electrical /Electronic Property Problem	37	37
Obstruction of Flow	24	24
Noise, Audible	18	18
High Readings	18	18
High Test Results	17	17
Infusion or Flow Problem	14	14
Leak/Splash	12	12
Fluid/Blood Leak	12	12
Mechanical Jam	11	11
Loose or Intermittent Connection	10	10
Temperature Problem	9	9
Low Test Results	9	9
Low Readings	9	9
Non Reproducible Results	8	8
Material Twisted/Bent	8	8
Display or Visual Feedback Problem	7	7
Computer Software Problem	7	7
Device Ingredient or Reagent Problem	6	6
Decreased Sensitivity	6	6
Failure to Pump	6	6
No Flow	5	5
Priming Problem	5	5
Intermittent Continuity	5	5
Break	4	4
Communication or Transmission Problem	4	4
Image Display Error/Artifact	4	4
Electrical Power Problem	4	4
Suction Failure	4	4
Suction Problem	4	4
Air/Gas in Device	4	4
Computer Operating System Problem	4	4
Electrical Shorting	3	3
Detachment of Device or Device Component	3	3
Calibration Problem	3	3
Display Difficult to Read	3	3
Volume Accuracy Problem	2	2
Use of Device Problem	2	2
Material Deformation	2	2
Data Problem	2	2
Partial Blockage	2	2
Intermittent Communication Failure	2	2
Degraded	2	2
Failure to Deliver	2	2
Device Sensing Problem	2	2
Deformation Due to Compressive Stress	2	2
Loss of Power	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1109	1109
Insufficient Information	2	2
Electric Shock	1	1