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TPLC
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show TPLC since
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Device
attachment, breathing, positive end expiratory pressure
Product Code
BYE
Regulation Number
868.5965
Device Class
2
Premarket Reviews
Manufacturer
Decision
A PLUS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
AIRWAYS DEVELOPMENT, LLC
SUBSTANTIALLY EQUIVALENT
1
BESMED HEALTH BUSINESS CORP.
SUBSTANTIALLY EQUIVALENT
1
DRAEGER MEDICAL AG & CO. KG
SUBSTANTIALLY EQUIVALENT
1
GALEMED CORP.
SUBSTANTIALLY EQUIVALENT
1
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MERCURY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
NEOFORCE GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
O-TWO MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
S & T MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
SEN MU TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
4
4
2017
3
3
2018
10
10
2019
5
5
2020
5
5
2021
4
4
2022
10
10
2023
8
8
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
6
6
Component Missing
5
5
Detachment of Device or Device Component
4
4
Misconnection
4
4
Defective Component
4
4
Pressure Problem
4
4
Break
3
3
Material Discolored
3
3
Disconnection
3
3
Fracture
3
3
Misassembled
3
3
Blocked Connection
3
3
Connection Problem
3
3
Fitting Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Device Operates Differently Than Expected
2
2
Loose or Intermittent Connection
2
2
Use of Device Problem
2
2
Key or Button Unresponsive/not Working
2
2
Output Problem
2
2
No Flow
2
2
Human-Device Interface Problem
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Medical Gas Supply Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Temperature Problem
1
1
Volume Accuracy Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanical Problem
1
1
Obstruction of Flow
1
1
Expiration Date Error
1
1
Low Battery
1
1
Defective Device
1
1
Device Packaging Compromised
1
1
Activation, Positioning or Separation Problem
1
1
Gas Output Problem
1
1
Gradient Increase
1
1
Insufficient Heating
1
1
Difficult to Insert
1
1
Labelling, Instructions for Use or Training Problem
1
1
Leak/Splash
1
1
Inaccurate Flow Rate
1
1
Detachment Of Device Component
1
1
Disassembly
1
1
Output above Specifications
1
1
Loss of Power
1
1
Unable to Obtain Readings
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Separation
1
1
Tidal Volume Fluctuations
1
1
Device Inoperable
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16
16
No Consequences Or Impact To Patient
9
9
No Known Impact Or Consequence To Patient
8
8
Insufficient Information
5
5
No Information
3
3
Unintended Extubation
3
3
Cardiopulmonary Arrest
3
3
Low Oxygen Saturation
3
3
Death
2
2
Hypoventilation
2
2
No Patient Involvement
2
2
Pain
1
1
Pneumothorax
1
1
Respiratory Distress Syndrome of Newborns
1
1
Ventricular Fibrillation
1
1
Aneurysm
1
1
Apnea
1
1
Arrhythmia
1
1
Atrial Fibrillation
1
1
Cardiac Arrest
1
1
Fatigue
1
1
Sleep Dysfunction
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Toxicity
1
1
Overinflation of Lung
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Airways Development LLC
II
Dec-24-2015
2
Westmed, Inc.
II
Jun-26-2020
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