TPLC - Total Product Life Cycle

show TPLC since

Device	transducer, blood-pressure, extravascular
Product Code	DRS
Regulation Number	870.2850
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	121	121
Fluid/Blood Leak	106	106
Disconnection	74	74
Break	60	60
Incorrect, Inadequate or Imprecise Result or Readings	37	37
Separation Failure	29	29
Separation Problem	23	23
Detachment of Device or Device Component	14	14
Unable to Obtain Readings	13	13
Pressure Problem	12	12
Inaccurate Information	12	12
Crack	12	12
Air/Gas in Device	11	11
Incorrect Measurement	10	10
Leak/Splash	9	9
No Flow	9	9
High Readings	8	8
Material Split, Cut or Torn	6	6
Connection Problem	6	6
Mechanical Problem	6	6
Device Markings/Labelling Problem	5	5
Device Sensing Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Reflux within Device	5	5
Output Problem	4	4
Failure to Zero	4	4
Material Integrity Problem	4	4
Loss of or Failure to Bond	4	4
Infusion or Flow Problem	4	4
Failure to Calibrate	3	3
Inappropriate Waveform	3	3
Backflow	3	3
Obstruction of Flow	3	3
Difficult to Insert	3	3
Incomplete or Inadequate Connection	2	2
Calibration Problem	2	2
Improper Flow or Infusion	2	2
Gas/Air Leak	2	2
Fail-Safe Problem	2	2
Contamination	2	2
Loose or Intermittent Connection	2	2
Activation, Positioning or Separation Problem	2	2
Display Difficult to Read	2	2
Difficult to Flush	2	2
Electrical /Electronic Property Problem	2	2
Material Puncture/Hole	2	2
Device Displays Incorrect Message	2	2
Defective Device	2	2
Melted	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	439	439
No Consequences Or Impact To Patient	78	78
Blood Loss	23	23
Insufficient Information	22	22
No Known Impact Or Consequence To Patient	19	19
Hemorrhage/Bleeding	18	18
No Patient Involvement	17	17
Death	3	3
Low Blood Pressure/ Hypotension	3	3
No Information	2	2
Discomfort	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pneumothorax	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Cardiac Arrest	1	1
Burn(s)	1	1
Exposure to Body Fluids	1	1
Respiratory Insufficiency	1	1
Atrial Flutter	1	1
Full thickness (Third Degree) Burn	1	1