TPLC - Total Product Life Cycle

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Device	monitor and/or control, level sensing, cardiopulmonary bypass
Product Code	DTW
Regulation Number	870.4340
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operational Issue	15	15
Device Alarm System	10	10
Device Displays Incorrect Message	9	9
Device Operates Differently Than Expected	8	8
False Alarm	8	8
No Display/Image	7	7
Device Sensing Problem	7	7
Failure to Power Up	6	6
Failure To Adhere Or Bond	5	5
Failure to Sense	5	5
Appropriate Term/Code Not Available	4	4
Break	4	4
Pumping Stopped	3	3
Other (for use when an appropriate device code cannot be identified)	3	3
Connection Problem	3	3
Delayed Alarm	2	2
Failure to Auto Stop	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Degraded	1	1
Disconnection	1	1
Out-Of-Box Failure	1	1
Failure to Calibrate	1	1
Low Readings	1	1
Bent	1	1
Defective Alarm	1	1
False Reading From Device Non-Compliance	1	1
Incorrect Measurement	1	1
No Device Output	1	1
Over-Sensing	1	1
Material Integrity Problem	1	1
No Flow	1	1
Output Problem	1	1
Pressure Problem	1	1
Insufficient Information	1	1
Device Stops Intermittently	1	1
Under-Sensing	1	1
Communication or Transmission Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	56	56
No Patient Involvement	42	42
No Clinical Signs, Symptoms or Conditions	5	5
No Known Impact Or Consequence To Patient	3	3
No Information	2	2
No Patient involvement	2	2
Patient Problem/Medical Problem	1	1
Ventilator Dependent	1	1
Insufficient Information	1	1
Seizures	1	1