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TPLC
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show TPLC since
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2024
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Device
ventilator, high frequency
Product Code
LSZ
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
39
39
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
586
586
Pressure Problem
60
60
Leak/Splash
25
25
Disconnection
13
13
No Pressure
11
11
Material Too Soft/Flexible
11
11
Improper Flow or Infusion
10
10
Overheating of Device
10
10
Infusion or Flow Problem
9
9
Connection Problem
9
9
Defective Component
9
9
Unexpected Shutdown
9
9
Gas/Air Leak
8
8
Decrease in Pressure
8
8
Failure to Cycle
8
8
Loose or Intermittent Connection
7
7
Fluid/Blood Leak
7
7
Calibration Problem
7
7
Display or Visual Feedback Problem
6
6
Device Alarm System
6
6
Inaccurate Flow Rate
5
5
Increase in Pressure
5
5
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
Incorrect Measurement
4
4
Defective Alarm
3
3
No Audible Alarm
3
3
Break
3
3
Contamination /Decontamination Problem
3
3
High Readings
3
3
Overfill
3
3
Product Quality Problem
3
3
Smoking
3
3
Insufficient Information
3
3
Noise, Audible
2
2
No Visual Prompts/Feedback
2
2
Device Emits Odor
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Protective Measures Problem
2
2
Circuit Failure
2
2
Crack
2
2
Electrical /Electronic Property Problem
2
2
Insufficient Heating
2
2
Loss of Power
2
2
Failure to Power Up
2
2
Failure to Run on Battery
1
1
Failure to Pump
1
1
Pumping Stopped
1
1
Fracture
1
1
Gas Output Problem
1
1
Melted
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
Output below Specifications
1
1
Output Problem
1
1
Detachment of Device or Device Component
1
1
Device Sensing Problem
1
1
Electrical Power Problem
1
1
Mechanical Jam
1
1
Moisture or Humidity Problem
1
1
Failure to Recalibrate
1
1
Tidal Volume Fluctuations
1
1
Insufficient Flow or Under Infusion
1
1
No Audible Prompt/Feedback
1
1
Failure to Calibrate
1
1
High Test Results
1
1
Component Missing
1
1
Failure to Align
1
1
Defective Device
1
1
Excessive Heating
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Unintended Application Program Shut Down
1
1
Incomplete or Inadequate Connection
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
673
673
No Patient Involvement
76
76
No Consequences Or Impact To Patient
71
71
No Information
22
22
Low Oxygen Saturation
19
19
No Known Impact Or Consequence To Patient
19
19
Insufficient Information
10
10
Bradycardia
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Hypoventilation
4
4
Pneumothorax
4
4
Aspiration/Inhalation
3
3
Death
2
2
Respiratory Acidosis
2
2
Bacterial Infection
2
2
Hypoxia
2
2
Respiratory Failure
1
1
Cardiac Arrest
1
1
No Code Available
1
1
Abnormal Blood Gases
1
1
Diminished Pulse Pressure
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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