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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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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
3
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
91
91
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
48
48
Device Displays Incorrect Message
39
39
Leak/Splash
34
34
Overheating of Device
30
30
Device Alarm System
27
27
Calibration Problem
26
26
Noise, Audible
24
24
Inaccurate Delivery
22
22
No Audible Alarm
21
21
Disconnection
21
21
Connection Problem
20
20
Decrease in Pressure
18
18
No Pressure
16
16
Loose or Intermittent Connection
15
15
Loss of Power
14
14
Unexpected Shutdown
13
13
Temperature Problem
13
13
Gas/Air Leak
13
13
Failure to Power Up
13
13
Improper Flow or Infusion
12
12
Defective Component
11
11
Material Too Soft/Flexible
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Display or Visual Feedback Problem
10
10
Appropriate Term/Code Not Available
10
10
Defective Alarm
10
10
Break
10
10
Infusion or Flow Problem
9
9
Inaccurate Flow Rate
8
8
Fluid/Blood Leak
8
8
Increase in Pressure
8
8
Moisture or Humidity Problem
7
7
Overfill
7
7
Moisture Damage
7
7
Incorrect Measurement
7
7
Power Problem
7
7
Smoking
7
7
False Alarm
6
6
High Readings
6
6
Thermal Decomposition of Device
6
6
Therapeutic or Diagnostic Output Failure
6
6
Use of Incorrect Control/Treatment Settings
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Insufficient Heating
5
5
Crack
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
721
721
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
31
31
Insufficient Information
13
13
Bradycardia
11
11
Death
10
10
Aspiration/Inhalation
9
9
Hypoxia
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Pneumothorax
5
5
Respiratory Acidosis
5
5
Respiratory Failure
5
5
Hypoventilation
4
4
No Code Available
4
4
Abnormal Blood Gases
4
4
Bacterial Infection
3
3
Apnea
1
1
Inadequate Osseointegration
1
1
Respiratory Distress
1
1
Malaise
1
1
Diminished Pulse Pressure
1
1
Cusp Tear
1
1
Cardiac Arrest
1
1
Hyperglycemia
1
1
Pneumonia
1
1
Pulmonary Edema
1
1
Loss of consciousness
1
1
Lethargy
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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