TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
3	2	4	4	2	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	457	457
Pressure Problem	56	56
No Device Output	20	20
Leak/Splash	18	18
No Pressure	18	18
Unexpected Shutdown	16	16
Improper Flow or Infusion	15	15
Gas/Air Leak	13	13
Disconnection	12	12
Material Too Soft/Flexible	12	12
Incorrect Measurement	11	11
Failure to Cycle	11	11
Decrease in Pressure	10	10
Connection Problem	10	10
Gas Output Problem	9	9
Defective Component	9	9
Overheating of Device	8	8
Inaccurate Flow Rate	7	7
High Readings	7	7
Loose or Intermittent Connection	7	7
Low Readings	7	7
Calibration Problem	6	6
Device Emits Odor	6	6
Device Alarm System	6	6
Appropriate Term/Code Not Available	5	5
Therapeutic or Diagnostic Output Failure	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Infusion or Flow Problem	5	5
Temperature Problem	5	5
Smoking	4	4
Power Problem	4	4
Insufficient Information	4	4
Adverse Event Without Identified Device or Use Problem	4	4
No Flow	4	4
Fluid/Blood Leak	4	4
Break	4	4
Failure to Align	4	4
Increase in Pressure	3	3
Product Quality Problem	3	3
Display or Visual Feedback Problem	3	3
Device Displays Incorrect Message	3	3
Use of Incorrect Control/Treatment Settings	3	3
Noise, Audible	3	3
Failure to Power Up	3	3
Contamination /Decontamination Problem	3	3
Overfill	3	3
Output Problem	3	3
Failure to Recalibrate	3	3
Circuit Failure	2	2
Key or Button Unresponsive/not Working	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	790	790
Insufficient Information	26	26
Low Oxygen Saturation	18	18
Bradycardia	6	6
Pneumothorax	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoventilation	4	4
Respiratory Acidosis	2	2
Bacterial Infection	2	2
Aspiration/Inhalation	1	1
Diminished Pulse Pressure	1	1
Cardiac Arrest	1	1
Overinflation of Lung	1	1
Increased Respiratory Rate	1	1
Hypoxia	1	1