TPLC - Total Product Life Cycle

show TPLC since

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	2	6	2	3	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Audible Prompt/Feedback Problem	250	250
Adverse Event Without Identified Device or Use Problem	162	162
Battery Problem	75	75
Appropriate Term/Code Not Available	61	61
Output Problem	57	57
No Apparent Adverse Event	39	39
Mechanical Problem	37	37
Electrical /Electronic Property Problem	34	34
Display or Visual Feedback Problem	28	28
Break	25	25
Material Integrity Problem	19	19
Noise, Audible	18	18
Material Puncture/Hole	16	16
Insufficient Information	12	12
Power Problem	11	11
Charging Problem	10	10
Fracture	8	8
Activation, Positioning or Separation Problem	5	5
Crack	5	5
Image Display Error/Artifact	4	4
Device Emits Odor	3	3
Material Deformation	3	3
No Display/Image	3	3
Failure to Charge	3	3
Computer Software Problem	2	2
Physical Resistance/Sticking	2	2
Pressure Problem	2	2
Mechanical Jam	2	2
Shipping Damage or Problem	1	4
Scratched Material	1	1
Program or Algorithm Execution Problem	1	1
Use of Device Problem	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Decrease in Pressure	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inflation Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Electrical Overstress	1	1
Product Quality Problem	1	4
Material Separation	1	1
Detachment of Device or Device Component	1	1
Defective Device	1	4
Failure to Calibrate	1	1
Protective Measures Problem	1	1
Material Split, Cut or Torn	1	1
Complete Loss of Power	1	1
Insufficient Cooling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	518	518
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	45
Multiple Organ Failure	40	40
Hemorrhage/Bleeding	30	30
Sepsis	22	22
Renal Impairment	22	22
Stroke/CVA	19	19
Respiratory Failure	19	19
Hemolysis	17	17
Bacterial Infection	15	15
Unspecified Infection	12	12
Thrombosis/Thrombus	10	10
Loss of consciousness	6	6
Thromboembolism	4	4
Insufficient Information	4	4
Convulsion/Seizure	3	3
Renal Failure	3	3
Hemorrhagic Stroke	3	3
Hypervolemia	2	2
Pulmonary Edema	2	2
Cardiomyopathy	2	2
Suicidal Ideation	2	2
Ischemia	2	2
Liver Failure	2	2
Septic Shock	1	1
Viral Infection	1	1
Cardiogenic Shock	1	1
Intracranial Hemorrhage	1	1
Transient Ischemic Attack	1	1
Unspecified Hepatic or Biliary Problem	1	1
Obstruction/Occlusion	1	1
Embolism/Embolus	1	1
Congenital Defect/Deformity	1	1
Heart Failure/Congestive Heart Failure	1	1
Inflammation	1	1
Anxiety	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Hypoxia	1	1
Aspiration/Inhalation	1	1
Bowel Perforation	1	1
Dizziness	1	1
Fungal Infection	1	1
Brain Injury	1	1
Low Blood Pressure/ Hypotension	1	1
Failure of Implant	1	1
Decreased Respiratory Rate	1	1