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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device artificial heart
Definition P030011
Product CodeLOZ
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
8 5 0 2 6 1

MDR Year MDR Reports MDR Events
2019 379 379
2020 264 264
2021 241 241
2022 152 152
2023 167 167
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Audible Prompt/Feedback Problem 443 443
Adverse Event Without Identified Device or Use Problem 256 256
Battery Problem 132 132
Mechanical Problem 125 125
Output Problem 91 91
Electrical /Electronic Property Problem 82 82
Appropriate Term/Code Not Available 67 67
No Apparent Adverse Event 64 64
Noise, Audible 36 36
Display or Visual Feedback Problem 34 34
Material Integrity Problem 26 26
Material Puncture/Hole 20 20
Image Display Error/Artifact 19 19
Break 16 16
Power Problem 15 15
Charging Problem 12 12
Failure to Charge 12 12
Insufficient Information 11 11
Fracture 8 8
Device Emits Odor 5 5
Activation, Positioning or Separation Problem 5 5
Contamination /Decontamination Problem 4 4
Temperature Problem 4 4
Crack 4 4
No Display/Image 3 3
Material Discolored 3 3
Material Deformation 3 3
Physical Resistance/Sticking 3 3
No Visual Prompts/Feedback 2 2
Material Split, Cut or Torn 2 2
Loose or Intermittent Connection 2 2
Connection Problem 2 2
Mechanical Jam 2 2
Pressure Problem 2 2
Degraded 2 2
No Audible Alarm 2 2
Premature Discharge of Battery 2 2
Computer Software Problem 2 2
Difficult to Insert 2 2
Leak/Splash 2 2
Failure to Calibrate 2 2
Material Too Rigid or Stiff 2 2
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
No Audible Prompt/Feedback 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Application Program Problem 1 1
Product Quality Problem 1 1
Radiation Leak 1 1
Overheating of Device 1 1
Insufficient Cooling 1 1
Corroded 1 1
Disconnection 1 1
Inflation Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Gas/Air Leak 1 1
Program or Algorithm Execution Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 585 585
No Consequences Or Impact To Patient 236 236
No Patient Involvement 215 215
Death 69 69
Multiple Organ Failure 59 59
Hemorrhage/Bleeding 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Respiratory Failure 36 36
Bacterial Infection 35 35
Sepsis 34 34
Hemolysis 26 26
Stroke/CVA 26 26
Renal Impairment 23 23
Loss of consciousness 21 21
Neurological Deficit/Dysfunction 19 19
Renal Failure 19 19
Patient Problem/Medical Problem 15 15
Unspecified Infection 13 13
Thrombosis/Thrombus 10 10
Fungal Infection 7 7
Thromboembolism 6 6
Liver Damage/Dysfunction 6 6
Hemorrhage, Cerebral 5 5
Viral Infection 5 5
Insufficient Information 5 5
Convulsion/Seizure 4 4
Urinary Tract Infection 4 4
Pulmonary Edema 3 3
Hemorrhagic Stroke 3 3
Hypervolemia 3 3
Bowel Perforation 3 3
Discomfort 2 2
Brain Injury 2 2
Coma 2 2
Suicidal Ideation 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 2 2
Liver Failure 2 2
Unspecified Hepatic or Biliary Problem 2 2
Ischemia 2 2
Dizziness 2 2
Encephalopathy 2 2
Cardiomyopathy 2 2
Cardiopulmonary Arrest 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Aspiration/Inhalation 1 1
Congenital Defect/Deformity 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Embolus 1 1
Hematoma 1 1
Inflammation 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1
Heart Failure 1 1
Blurred Vision 1 1
Seizures 1 1
Septic Shock 1 1
Shock 1 2
Thrombosis 1 1
Transient Ischemic Attack 1 1
Skin Inflammation/ Irritation 1 1
Heart Failure/Congestive Heart Failure 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Embolism/Embolus 1 1
Obstruction/Occlusion 1 1
Depression 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Decreased Respiratory Rate 1 1
Low Cardiac Output 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SynCardia Systems LLC II Oct-20-2023
2 SynCardia Systems LLC II Jan-27-2023
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