TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	119	119
Fluid/Blood Leak	111	111
Disconnection	61	61
Break	55	55
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Separation Failure	28	28
Air/Gas in Device	23	23
Separation Problem	20	20
Crack	18	18
Inaccurate Information	17	17
Detachment of Device or Device Component	15	15
Unable to Obtain Readings	14	14
No Flow	14	14
Incorrect Measurement	13	13
Pressure Problem	12	12
Leak/Splash	10	10
High Readings	9	9
Material Split, Cut or Torn	7	7
Reflux within Device	5	5
Device Markings/Labelling Problem	5	5
Device Sensing Problem	5	5
Output Problem	4	4
Failure to Zero	4	4
Connection Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Backflow	4	4
Material Integrity Problem	4	4
Mechanical Problem	3	3
Infusion or Flow Problem	3	3
Difficult to Insert	3	3
Obstruction of Flow	3	3
Inappropriate Waveform	3	3
Incomplete or Inadequate Connection	2	2
Failure to Calibrate	2	2
Gas/Air Leak	2	2
Loose or Intermittent Connection	2	2
Contamination	2	2
Material Puncture/Hole	2	2
Display Difficult to Read	2	2
Electrical /Electronic Property Problem	2	2
Loss of or Failure to Bond	2	2
Fail-Safe Problem	2	2
Defective Device	2	2
Deformation Due to Compressive Stress	2	2
Difficult to Flush	2	2
Calibration Problem	2	2
Improper Flow or Infusion	2	2
Complete Blockage	1	1
Imprecision	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	508	508
Hemorrhage/Bleeding	26	26
Insufficient Information	23	23
No Consequences Or Impact To Patient	20	20
No Patient Involvement	8	8
No Known Impact Or Consequence To Patient	8	8
Blood Loss	6	6
Death	3	3
Thrombosis/Thrombus	2	2
Low Blood Pressure/ Hypotension	2	2
Discomfort	2	2
Cardiac Arrest	1	1
Respiratory Insufficiency	1	1
Air Embolism	1	1
Burn(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Full thickness (Third Degree) Burn	1	1
Extravasation	1	1