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	33	33
Leak/Splash	17	17
Fluid/Blood Leak	16	16
Incorrect, Inadequate or Imprecise Result or Readings	15	15
Failure to Calibrate	12	12
Data Problem	12	12
Display or Visual Feedback Problem	11	11
Failure to Sense	9	9
Failure to Zero	8	8
Detachment of Device or Device Component	8	8
Loose or Intermittent Connection	8	8
Air/Gas in Device	8	8
No Display/Image	7	7
Disconnection	6	6
Tear, Rip or Hole in Device Packaging	6	6
Connection Problem	6	6
Device Sensing Problem	5	5
Break	5	5
Fracture	5	5
Inappropriate Waveform	4	4
Defective Device	4	4
Difficult to Open or Close	3	3
Mechanical Problem	3	3
Erratic Results	3	3
Material Deformation	3	3
Pressure Problem	2	2
Insufficient Information	2	2
No Device Output	2	2
Failure to Recalibrate	2	2
Crack	2	2
Backflow	2	2
Gas/Air Leak	2	2
Calibration Problem	2	2
Obstruction of Flow	2	2
Defective Component	2	2
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Material Separation	1	1
High Sensing Threshold	1	1
Device Alarm System	1	1
Flushing Problem	1	1
Excess Flow or Over-Infusion	1	1
Decrease in Pressure	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	133	133
Insufficient Information	18	18
No Patient Involvement	5	5
No Consequences Or Impact To Patient	2	2
Perforation of Esophagus	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
Skin Erosion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	II	Sep-18-2015