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
Leak/Splash	9	9
Fluid/Blood Leak	9	10
Electrical Power Problem	5	5
Inaccurate Information	5	5
Smoking	5	5
Break	4	4
Low Readings	3	3
Unable to Obtain Readings	3	3
Detachment of Device or Device Component	3	3
Intermittent Communication Failure	2	2
Material Fragmentation	2	2
Battery Problem	2	2
Insufficient Flow or Under Infusion	2	2
High Readings	2	3
Temperature Problem	2	2
Ambient Temperature Problem	2	2
Excessive Heating	1	1
Failure to Transmit Record	1	1
Output Problem	1	1
Communication or Transmission Problem	1	2
Unexpected Shutdown	1	1
Sparking	1	1
Material Separation	1	2

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	116	122
No Known Impact Or Consequence To Patient	78	78
No Patient Involvement	15	15
Insufficient Information	2	2
Superficial (First Degree) Burn	2	2
No Information	1	2
Stroke/CVA	1	1
High Blood Pressure/ Hypertension	1	1
Reaction	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
No Code Available	1	1
Alteration In Body Temperature	1	1