TPLC - Total Product Life Cycle

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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
Mechanical Problem	6	6
Connection Problem	6	6
Reflux within Device	5	5
Device Markings/Labelling Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Device Sensing Problem	5	5
Loss of or Failure to Bond	4	4
Output Problem	4	4
Infusion or Flow Problem	4	4
Failure to Zero	4	4
Material Integrity Problem	4	4
Failure to Calibrate	3	3
Obstruction of Flow	3	3
Backflow	3	3
Difficult to Insert	3	3
Inappropriate Waveform	3	3
Contamination	2	2
Fail-Safe Problem	2	2
Activation, Positioning or Separation Problem	2	2
Defective Device	2	2
Gas/Air Leak	2	2
Improper Flow or Infusion	2	2
Device Displays Incorrect Message	2	2
Loose or Intermittent Connection	2	2
Electrical /Electronic Property Problem	2	2
Calibration Problem	2	2
Material Puncture/Hole	2	2
Difficult to Flush	2	2
Incomplete or Inadequate Connection	2	2
Display Difficult to Read	2	2
No Device Output	1	1
Unintended Collision	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
Cardiac Arrest	1	1
Chronic Obstructive Pulmonary Disease (COPD)	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