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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	50	53
Incorrect Measurement	34	34
Leak/Splash	9	9
Fluid/Blood Leak	9	10
Inaccurate Information	5	5
Break	4	4
Unable to Obtain Readings	3	3
Detachment of Device or Device Component	3	3
High Readings	2	3
Material Fragmentation	2	2
Battery Problem	2	2
Insufficient Flow or Under Infusion	2	2
Low Readings	2	2
Intermittent Communication Failure	2	2
Sparking	1	1
Unexpected Shutdown	1	1
Fire	1	1
Communication or Transmission Problem	1	2
Output Problem	1	1
Failure to Transmit Record	1	1
Material Separation	1	2
Excessive Heating	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	115	121
Insufficient Information	2	2
No Consequences Or Impact To Patient	2	2
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ICU Medical, Inc.	II	Jan-14-2021