TPLC - Total Product Life Cycle

show TPLC since

Device	probe, blood-flow, extravascular
Product Code	DPT
Regulation Number	870.2120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unable to Obtain Readings	17	17
Leak/Splash	16	16
Fluid/Blood Leak	14	14
Loose or Intermittent Connection	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Air/Gas in Device	8	8
Data Problem	6	6
Connection Problem	6	6
Display or Visual Feedback Problem	6	6
Disconnection	6	6
Device Sensing Problem	5	5
Failure to Zero	4	4
Inappropriate Waveform	4	4
Failure to Sense	3	3
Difficult to Open or Close	3	3
Detachment of Device or Device Component	3	3
No Display/Image	3	3
Mechanical Problem	3	3
Failure to Calibrate	3	3
Fracture	2	2
Break	2	2
Crack	2	2
Defective Component	2	2
Obstruction of Flow	2	2
Gas/Air Leak	2	2
Pressure Problem	2	2
Material Separation	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
High Sensing Threshold	1	1
Defective Device	1	1
Calibration Problem	1	1
Device Alarm System	1	1
Flushing Problem	1	1
Excess Flow or Over-Infusion	1	1
Failure to Recalibrate	1	1
No Device Output	1	1
Decrease in Pressure	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	91	91
Insufficient Information	18	18
No Consequences Or Impact To Patient	2	2
Ischemic Heart Disease	1	1
No Known Impact Or Consequence To Patient	1	1
Valvular Insufficiency/ Regurgitation	1	1
Bradycardia	1	1
Death	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoxia	1	1