Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
ventilator, high frequency
Product Code
LSZ
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
68
68
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
Loose or Intermittent Connection
15
15
No Pressure
15
15
Loss of Power
14
14
Failure to Power Up
13
13
Temperature Problem
13
13
Improper Flow or Infusion
12
12
Unexpected Shutdown
12
12
Material Too Soft/Flexible
11
11
Defective Component
11
11
Gas/Air Leak
10
10
Appropriate Term/Code Not Available
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
Inaccurate Flow Rate
7
7
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
False Alarm
6
6
Thermal Decomposition of Device
6
6
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
High Readings
4
4
Low Readings
4
4
Failure to Calibrate
4
4
Sticking
4
4
Device Emits Odor
4
4
No Device Output
4
4
Device Maintenance Issue
4
4
Incorrect Measurement
4
4
Alarm Not Visible
4
4
Use of Incorrect Control/Treatment Settings
3
3
Calibration Error
3
3
Erratic or Intermittent Display
3
3
No Display/Image
3
3
Material Separation
3
3
Product Quality Problem
3
3
Device Damaged Prior to Use
3
3
Contamination /Decontamination Problem
3
3
Naturally Worn
3
3
No Flow
2
2
Ventilation Problem in Device Environment
2
2
Output Problem
2
2
No Visual Prompts/Feedback
2
2
Protective Measures Problem
2
2
Improper Device Output
2
2
Microbial Contamination of Device
2
2
Failure to Align
2
2
Failure to Recalibrate
2
2
Failure to Reset
2
2
Self-Activation or Keying
2
2
Melted
2
2
Pumping Stopped
2
2
Device Difficult to Program or Calibrate
2
2
Fire
2
2
Restricted Flow rate
2
2
Circuit Failure
2
2
Detachment Of Device Component
2
2
Component Falling
2
2
Intermittent Continuity
1
1
Degraded
1
1
Unintended Power Up
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
Failure to Pump
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
701
701
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
-
-