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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)
2019 2020 2021 2022 2023 2024
3 2 3 2 4 1

MDR Year MDR Reports MDR Events
2019 88 88
2020 154 154
2021 224 224
2022 220 220
2023 186 186
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 585 585
Pressure Problem 60 60
Leak/Splash 25 25
Disconnection 12 12
Material Too Soft/Flexible 11 11
Unexpected Shutdown 9 9
Overheating of Device 9 9
Connection Problem 9 9
Improper Flow or Infusion 9 9
Infusion or Flow Problem 9 9
Failure to Cycle 8 8
Decrease in Pressure 7 7
Loose or Intermittent Connection 7 7
Fluid/Blood Leak 7 7
Defective Component 7 7
Calibration Problem 7 7
Gas/Air Leak 6 6
No Pressure 6 6
Display or Visual Feedback Problem 6 6
Device Alarm System 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Temperature Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Appropriate Term/Code Not Available 5 5
Power Problem 4 4
Device Displays Incorrect Message 4 4
Inaccurate Flow Rate 4 4
Incorrect Measurement 4 4
Increase in Pressure 4 4
No Audible Alarm 3 3
Break 3 3
Contamination /Decontamination Problem 3 3
Overfill 3 3
High Readings 3 3
Product Quality Problem 3 3
Smoking 3 3
Insufficient Information 3 3
Protective Measures Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Circuit Failure 2 2
Crack 2 2
Electrical /Electronic Property Problem 2 2
Loss of Power 2 2
Failure to Power Up 2 2
Insufficient Heating 2 2
Device Emits Odor 2 2
Defective Alarm 2 2
Noise, Audible 2 2
No Visual Prompts/Feedback 2 2
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unintended Application Program Shut Down 1 1
Suction Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Intermittent Loss of Power 1 1
Fracture 1 1
Gas Output Problem 1 1
Melted 1 1
Failure to Run on Battery 1 1
Failure to Pump 1 1
Filling Problem 1 1
Restricted Flow rate 1 1
Degraded 1 1
Unintended Power Up 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Thermal Decomposition of Device 1 1
Alarm Not Visible 1 1
False Alarm 1 1
Failure to Align 1 1
Defective Device 1 1
Failure to Calibrate 1 1
High Test Results 1 1
Tidal Volume Fluctuations 1 1
Insufficient Flow or Under Infusion 1 1
No Audible Prompt/Feedback 1 1
Failure to Recalibrate 1 1
Component Missing 1 1
Output below Specifications 1 1
Output Problem 1 1
Mechanical Jam 1 1
Moisture or Humidity Problem 1 1
Detachment of Device or Device Component 1 1
Device Sensing Problem 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 656 656
No Patient Involvement 76 76
No Consequences Or Impact To Patient 71 71
No Information 22 22
No Known Impact Or Consequence To Patient 19 19
Low Oxygen Saturation 19 19
Insufficient Information 10 10
Bradycardia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pneumothorax 4 4
Hypoventilation 4 4
Aspiration/Inhalation 3 3
Hypoxia 2 2
Death 2 2
Respiratory Acidosis 2 2
Respiratory Failure 1 1
Lethargy 1 1
Diminished Pulse Pressure 1 1
No Code Available 1 1
Abnormal Blood Gases 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bunnell, Inc. II Dec-03-2022
2 Vyaire Medical II Dec-05-2023
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