TPLC - Total Product Life Cycle

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Device	computer, diagnostic, pre-programmed, single-function
Regulation Description	Single-function, preprogrammed diagnostic computer.
Product Code	DXG
Regulation Number	870.1435
Device Class	2

Premarket Reviews
Manufacturer	Decision
CARETAKER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
DIRECTED SYSTEMS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PULSION MEDICAL SYSTEMS SE
	SUBSTANTIALLY EQUIVALENT	1
1. K192169 PulsioFlex Monitoring System with ProAQT Sensor

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	71	71
Incorrect, Inadequate or Imprecise Result or Readings	69	72
Fluid/Blood Leak	9	10
Leak/Splash	8	8
Smoking	5	5
Inaccurate Information	5	5
Output Problem	4	4
Break	4	4
Battery Problem	4	4
Fire	3	3
Device Alarm System	3	3
Therapeutic or Diagnostic Output Failure	3	3
Unable to Obtain Readings	3	3
Detachment of Device or Device Component	3	3
Electrical Power Problem	2	2
High Readings	2	3
Material Fragmentation	2	2
Insufficient Flow or Under Infusion	2	2
High Test Results	2	2
Low Readings	2	2
Device Displays Incorrect Message	2	2
Intermittent Communication Failure	2	2
Temperature Problem	2	2
Unexpected Shutdown	1	1
Sparking	1	1
No Display/Image	1	1
Communication or Transmission Problem	1	2
Failure to Transmit Record	1	1
Material Separation	1	2
Increase in Pressure	1	1
Power Problem	1	1
Excessive Heating	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	114	120
No Consequences Or Impact To Patient	47	47
No Known Impact Or Consequence To Patient	22	22
No Patient Involvement	6	6
Insufficient Information	2	2
High Blood Pressure/ Hypertension	1	1
Alteration In Body Temperature	1	1
Reaction	1	1