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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, high frequency
Product CodeLSZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 1 0 1 3 2 4 3 3 3 3 2 3 2 4 1

MDR Year MDR Reports MDR Events
2014 29 29
2015 195 195
2016 394 394
2017 140 140
2018 88 88
2019 88 88
2020 154 154
2021 224 224
2022 220 220
2023 186 186
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 609 609
Device Operates Differently Than Expected 421 421
Pressure Problem 98 98
Device Stops Intermittently 88 88
Device Inoperable 55 55
Failure to Cycle 47 47
Device Displays Incorrect Message 39 39
Leak/Splash 34 34
Overheating of Device 28 28
Device Alarm System 27 27
Calibration Problem 26 26
Noise, Audible 23 23
Inaccurate Delivery 22 22
No Audible Alarm 21 21
Disconnection 21 21
Connection Problem 20 20
Decrease in Pressure 17 17
Loss of Power 14 14
No Pressure 14 14
Temperature Problem 13 13
Failure to Power Up 13 13
Loose or Intermittent Connection 13 13
Improper Flow or Infusion 12 12
Defective Component 11 11
Material Too Soft/Flexible 11 11
Unexpected Shutdown 10 10
Appropriate Term/Code Not Available 10 10
Gas/Air Leak 10 10
Display or Visual Feedback Problem 10 10
Break 10 10
Defective Alarm 10 10
Infusion or Flow Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Fluid/Blood Leak 8 8
Increase in Pressure 8 8
Moisture Damage 7 7
Smoking 7 7
Power Problem 7 7
Moisture or Humidity Problem 7 7
Therapeutic or Diagnostic Output Failure 6 6
Overfill 6 6
Inaccurate Flow Rate 6 6
Thermal Decomposition of Device 6 6
False Alarm 5 5
Crack 5 5
Insufficient Heating 5 5
Electrical /Electronic Property Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Out-Of-Box Failure 5 5
Insufficient Information 5 5
Failure to Calibrate 4 4
Sticking 4 4
Device Emits Odor 4 4
Device Maintenance Issue 4 4
Incorrect Measurement 4 4
Alarm Not Visible 4 4
Calibration Error 3 3
Erratic or Intermittent Display 3 3
No Display/Image 3 3
Product Quality Problem 3 3
Material Separation 3 3
Contamination /Decontamination Problem 3 3
High Readings 3 3
Naturally Worn 3 3
Device Damaged Prior to Use 3 3
Improper Device Output 2 2
No Flow 2 2
Output Problem 2 2
Ventilation Problem in Device Environment 2 2
Protective Measures Problem 2 2
No Visual Prompts/Feedback 2 2
Low Readings 2 2
Microbial Contamination of Device 2 2
Self-Activation or Keying 2 2
Pumping Stopped 2 2
Failure to Reset 2 2
Device Difficult to Program or Calibrate 2 2
Melted 2 2
Fire 2 2
Restricted Flow rate 2 2
Circuit Failure 2 2
Detachment Of Device Component 2 2
Component Falling 2 2
Use of Incorrect Control/Treatment Settings 2 2
Degraded 1 1
Unintended Power Up 1 1
Intermittent Continuity 1 1
Burst Container or Vessel 1 1
Air Leak 1 1
False Reading From Device Non-Compliance 1 1
Filling Problem 1 1
Image Display Error/Artifact 1 1
Imprecision 1 1
Fracture 1 1
Gas Output Problem 1 1
Occlusion Within Device 1 1
Failure to Run on Battery 1 1
Power Conditioning Problem 1 1
Failure to Pump 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 687 687
No Consequences Or Impact To Patient 377 377
No Patient Involvement 329 329
No Known Impact Or Consequence To Patient 146 146
No Information 143 143
Low Oxygen Saturation 30 30
Bradycardia 11 11
Insufficient Information 11 11
Death 10 10
Aspiration/Inhalation 8 8
Hypoxia 7 7
Pneumothorax 5 5
Respiratory Acidosis 5 5
Respiratory Failure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Code Available 4 4
Hypoventilation 4 4
Abnormal Blood Gases 4 4
Bacterial Infection 3 3
Apnea 1 1
Hyperglycemia 1 1
Cardiac Arrest 1 1
Lethargy 1 1
Diminished Pulse Pressure 1 1
Pulmonary Edema 1 1
Respiratory Distress 1 1
Pneumonia 1 1
Inadequate Osseointegration 1 1
Cusp Tear 1 1
Malaise 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bunnell, Inc. II Dec-03-2022
2 Bunnell, Inc. I Dec-14-2012
3 Bunnell, Inc. II Jan-14-2011
4 Vyaire Medical II Dec-05-2023
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