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 Measurement	137	137
Incorrect, Inadequate or Imprecise Result or Readings	57	60
Fluid/Blood Leak	10	11
Leak/Splash	9	9
Electrical Power Problem	5	5
Smoking	5	5
Inaccurate Information	5	5
Break	4	4
Unable to Obtain Readings	3	3
Low 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
Ambient Temperature Problem	2	2
Intermittent Communication Failure	2	2
Temperature Problem	2	2
Sparking	1	1
Unexpected Shutdown	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 Consequences Or Impact To Patient	119	119
No Clinical Signs, Symptoms or Conditions	117	123
No Known Impact Or Consequence To Patient	78	78
No Patient Involvement	15	15
Superficial (First Degree) Burn	2	2
Insufficient Information	2	2
High Blood Pressure/ Hypertension	1	1
Stroke/CVA	1	1
No Code Available	1	1
No Information	1	2
Alteration In Body Temperature	1	1
Reaction	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1