Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device artificial heart
Definition P030011
Product CodeLOZ
Device Class 3

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

MDR Year MDR Reports MDR Events
2014 325 325
2015 421 421
2016 422 422
2017 291 291
2018 569 569
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
Device Displays Incorrect Message 703 703
Audible Prompt/Feedback Problem 529 529
Adverse Event Without Identified Device or Use Problem 488 488
Device Operates Differently Than Expected 332 332
Battery Problem 284 284
Noise, Audible 221 221
Mechanical Problem 201 201
Appropriate Term/Code Not Available 159 159
Electrical /Electronic Property Problem 136 136
Output Problem 106 106
Power Problem 92 92
No Apparent Adverse Event 89 89
Break 81 81
Failure to Charge 78 78
Charging Problem 76 76
Device Alarm System 69 69
Display or Visual Feedback Problem 64 64
Connection Problem 46 46
Device Operational Issue 40 40
Device Inoperable 38 38
Physical Property Issue 36 36
Material Integrity Problem 32 32
No Display/Image 32 32
Loose or Intermittent Connection 32 32
Filling Problem 29 29
Image Display Error/Artifact 29 29
Crack 24 24
Difficult to Insert 23 23
Material Puncture/Hole 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
Torn Material 13 13
Computer Operating System Problem 13 13
Material Discolored 13 13
Defective Alarm 13 13
Failure to Power Up 13 13
Fracture 12 12
Device Emits Odor 11 11
Failure of Device to Self-Test 10 10
Pressure Problem 10 10
Calibration Problem 9 9
Material Too Rigid or Stiff 9 9
Pumping Stopped 9 9
Sticking 9 9
Improper or Incorrect Procedure or Method 8 8
Use of Device Problem 8 8
Self-Activation or Keying 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Material Rupture 7 7
Volume Accuracy Problem 7 7
Low Readings 7 7
Incorrect Or Inadequate Test Results 7 7
Overheating of Device 7 7
Positioning Problem 7 7
Improper Device Output 6 6
Loss of Power 6 6
Leak/Splash 6 6
Erratic or Intermittent Display 6 6
Failure to Calibrate 6 6
Device Issue 6 6
Communication or Transmission Problem 6 6
Activation, Positioning or Separation Problem 5 5
Failure to Align 5 5
Defective Component 5 5
Device Slipped 5 5
Application Interface Becomes Non-Functional Or Program Exits Abnormally 5 5
Failure To Run On AC/DC 5 5
Material Frayed 5 5
Human Factors Issue 5 5
Mechanical Jam 5 5
Improper Alarm 4 4
Output below Specifications 4 4
Therapeutic or Diagnostic Output Failure 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4
No Audible Alarm 4 4
Computer Software Problem 4 4
Intermittent Continuity 4 4
Material Separation 4 4
Component Missing 4 4
Overfill 4 4
High Readings 4 4
Device Sensing Problem 4 4
Contamination /Decontamination Problem 4 4
Split 3 3
Failure to Disconnect 3 3
Vibration 3 3
Short Fill 3 3
Failure to Sense 3 3
Failure to Cycle 3 3

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 Patient Involvement 593 593
No Clinical Signs, Symptoms or Conditions 586 586
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 44 44
Hemolysis 40 40
Sepsis 35 35
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
Thrombosis/Thrombus 11 11
Viral Infection 11 11
Discomfort 10 10
Complaint, Ill-Defined 8 8
Dyspnea 8 8
Pulmonary Embolism 6 6
Hemorrhage, Cerebral 6 6
Fall 6 6
Pulmonary Edema 6 6
Insufficient Information 6 6
Hypervolemia 5 5
Pericardial Effusion 5 5
Fatigue 5 5
Encephalopathy 5 5
Wound Dehiscence 5 5
Cardiomyopathy 5 5
Headache 4 4
Right Ventricular Failure 4 4
Convulsion/Seizure 4 4
Hemorrhagic Stroke 3 3
Bowel Perforation 3 3
Liver Failure 3 3
Ischemia 3 3
Respiratory Distress 3 3
Failure of Implant 3 3
Intracranial Hemorrhage 3 3
Edema 3 3
Cardiac Arrest 2 2
Syncope 2 2
Low Blood Pressure/ Hypotension 2 2
Hematoma 2 2
Incontinence 2 2
Pulmonary Dysfunction 2 2
Seizures 2 2
Heart Failure 2 2
Brain Injury 2 2
Tachycardia 2 2
Thrombus 2 2
Blurred Vision 2 2
Vomiting 2 2
Unspecified Hepatic or Biliary Problem 2 2
Heart Failure/Congestive Heart Failure 2 2
Decreased Respiratory Rate 2 2
Collapse 2 2
Coma 2 2
Anxiety 2 2
Unspecified Nervous System Problem 2 2
Suicidal Ideation 2 2
Lethargy 2 2
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Embolism/Embolus 1 1
Depression 1 1
Obstruction/Occlusion 1 1
Chest Tightness/Pressure 1 1
Palpitations 1 1
Pallor 1 1
Skin Inflammation/ Irritation 1 1
Weakness 1 1
Tingling 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Thrombosis 1 1
Hypovolemia 1 1
Cardiogenic Shock 1 1
Urinary Frequency 1 1
Vertigo 1 1
Septic Shock 1 1
Shock 1 2

Recalls
Manufacturer Recall Class Date Posted
1 SynCardia Systems Inc. I Dec-08-2016
2 SynCardia Systems Inc. I Sep-17-2015
3 SynCardia Systems LLC II Oct-20-2023
4 SynCardia Systems LLC II Jan-27-2023
-
-