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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 3

MDR Year MDR Reports MDR Events
2019 88 88
2020 154 154
2021 224 224
2022 220 220
2023 186 186
2024 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 586 586
Pressure Problem 61 61
Leak/Splash 25 25
No Pressure 15 15
Disconnection 13 13
Gas/Air Leak 13 13
Unexpected Shutdown 12 12
Overheating of Device 12 12
Material Too Soft/Flexible 11 11
Improper Flow or Infusion 10 10
Failure to Cycle 10 10
Connection Problem 9 9
Infusion or Flow Problem 9 9
Decrease in Pressure 9 9
Loose or Intermittent Connection 9 9
Defective Component 9 9
Inaccurate Flow Rate 7 7
Fluid/Blood Leak 7 7
Calibration Problem 7 7
Display or Visual Feedback Problem 7 7
Incorrect Measurement 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Device Alarm System 6 6
High Readings 6 6
Therapeutic or Diagnostic Output Failure 5 5
Appropriate Term/Code Not Available 5 5
No Device Output 5 5
Temperature Problem 5 5
Increase in Pressure 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Overfill 4 4
Failure to Recalibrate 4 4
Device Displays Incorrect Message 4 4
Insufficient Information 4 4
Power Problem 4 4
Smoking 3 3
No Audible Alarm 3 3
Contamination /Decontamination Problem 3 3
Product Quality Problem 3 3
Low Readings 3 3
Use of Incorrect Control/Treatment Settings 3 3
Noise, Audible 3 3
Defective Alarm 3 3
Break 3 3
Device Emits Odor 2 2
False Alarm 2 2
Protective Measures Problem 2 2
Insufficient Heating 2 2
Failure to Calibrate 2 2
Failure to Align 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 721 721
No Patient Involvement 76 76
No Consequences Or Impact To Patient 71 71
No Information 22 22
Low Oxygen Saturation 20 20
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 13 13
Bradycardia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pneumothorax 4 4
Hypoventilation 4 4
Aspiration/Inhalation 4 4
Death 2 2
Respiratory Acidosis 2 2
Hypoxia 2 2
Bacterial Infection 2 2
No Code Available 1 1
Abnormal Blood Gases 1 1
Diminished Pulse Pressure 1 1
Cardiac Arrest 1 1
Respiratory Failure 1 1
Lethargy 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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