TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
1	2	2	5	3	7	7	10	11	5	8	5	0	2	6	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	703	703
Audible Prompt/Feedback Problem	552	552
Adverse Event Without Identified Device or Use Problem	493	493
Device Operates Differently Than Expected	332	332
Battery Problem	292	292
Noise, Audible	222	222
Mechanical Problem	202	202
Appropriate Term/Code Not Available	161	161
Electrical /Electronic Property Problem	137	137
Output Problem	111	111
Power Problem	94	94
No Apparent Adverse Event	89	89
Break	87	87
Charging Problem	80	80
Failure to Charge	78	78
Device Alarm System	69	69
Display or Visual Feedback Problem	67	67
Connection Problem	46	46
Device Operational Issue	40	40
Device Inoperable	38	38
Physical Property Issue	36	36
Material Integrity Problem	33	33
No Display/Image	32	32
Loose or Intermittent Connection	32	32
Filling Problem	29	29
Image Display Error/Artifact	29	29
Material Puncture/Hole	24	24
Crack	24	24
Difficult to Insert	23	23
Premature Discharge of Battery	22	22
Insufficient Information	22	22
Low Battery	20	20
Device Stops Intermittently	19	19
Temperature Problem	18	18
Detachment Of Device Component	17	17
Air Leak	17	17
False Alarm	16	16
Component Falling	15	15
Disconnection	15	15
Difficult to Remove	14	14
Device Dislodged or Dislocated	14	14
Material Discolored	13	13
Failure to Power Up	13	13
Defective Alarm	13	13
Computer Operating System Problem	13	13
Torn Material	13	13
Fracture	12	12
Device Emits Odor	11	11
Pressure Problem	11	11
Failure of Device to Self-Test	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1155	1155
No Known Impact Or Consequence To Patient	984	984
No Clinical Signs, Symptoms or Conditions	618	618
No Patient Involvement	593	593
Death	231	231
Bacterial Infection	133	133
Respiratory Failure	127	127
Hemorrhage/Bleeding	106	106
Renal Failure	102	102
Multiple Organ Failure	98	98
Neurological Deficit/Dysfunction	86	86
Loss of consciousness	63	63
Patient Problem/Medical Problem	50	50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	48
Hemolysis	40	40
Sepsis	36	36
Liver Damage/Dysfunction	34	34
No Information	32	32
Stroke/CVA	31	31
No Code Available	30	30
Fungal Infection	27	27
High Blood Pressure/ Hypertension	26	26
Renal Impairment	24	24
Urinary Tract Infection	21	21
Unspecified Infection	20	20
Thromboembolism	15	15
Dizziness	13	13
Low Cardiac Output	13	13
Viral Infection	11	11
Thrombosis/Thrombus	11	11
Discomfort	10	10
Dyspnea	8	8
Complaint, Ill-Defined	8	8
Fall	6	6
Insufficient Information	6	6
Pulmonary Embolism	6	6
Hemorrhage, Cerebral	6	6
Pulmonary Edema	6	6
Hypervolemia	5	5
Fatigue	5	5
Encephalopathy	5	5
Cardiomyopathy	5	5
Wound Dehiscence	5	5
Pericardial Effusion	5	5
Headache	4	4
Right Ventricular Failure	4	4
Convulsion/Seizure	4	4
Intracranial Hemorrhage	3	3
Hemorrhagic Stroke	3	3
Edema	3	3