TPLC - Total Product Life Cycle

show TPLC since

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
2	3	2	4	4	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	538	538
Pressure Problem	52	52
Leak/Splash	25	25
No Device Output	16	16
No Pressure	16	16
Unexpected Shutdown	13	13
Gas/Air Leak	13	13
Disconnection	11	11
Material Too Soft/Flexible	11	11
Overheating of Device	10	10
Incorrect Measurement	10	10
Improper Flow or Infusion	10	10
Infusion or Flow Problem	9	9
Loose or Intermittent Connection	8	8
Connection Problem	8	8
Defective Component	8	8
Decrease in Pressure	8	8
Appropriate Term/Code Not Available	7	7
Low Readings	7	7
Calibration Problem	7	7
Failure to Cycle	6	6
High Readings	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Inaccurate Flow Rate	6	6
Temperature Problem	5	5
Display or Visual Feedback Problem	5	5
Device Alarm System	5	5
Fluid/Blood Leak	4	4
Power Problem	4	4
Insufficient Information	4	4
Failure to Recalibrate	4	4
Therapeutic or Diagnostic Output Failure	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Noise, Audible	3	3
Gas Output Problem	3	3
Increase in Pressure	3	3
Device Emits Odor	3	3
Use of Incorrect Control/Treatment Settings	3	3
Contamination /Decontamination Problem	3	3
Overfill	3	3
Smoking	3	3
Circuit Failure	2	2
Break	2	2
Output Problem	2	2
Device Displays Incorrect Message	2	2
No Visual Prompts/Feedback	2	2
Electrical /Electronic Property Problem	2	2
Insufficient Heating	2	2
Protective Measures Problem	2	2
Failure to Calibrate	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	753	753
No Patient Involvement	48	48
No Consequences Or Impact To Patient	28	28
Low Oxygen Saturation	19	19
No Information	17	17
Insufficient Information	14	14
No Known Impact Or Consequence To Patient	10	10
Bradycardia	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hypoventilation	4	4
Pneumothorax	3	3
Aspiration/Inhalation	3	3
Death	2	2
Respiratory Acidosis	2	2
Hypoxia	2	2
Bacterial Infection	2	2
Abnormal Blood Gases	1	1
Diminished Pulse Pressure	1	1
Cardiac Arrest	1	1
Increased Respiratory Rate	1	1
Respiratory Failure	1	1