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TPLC
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Device
attachment, breathing, positive end expiratory pressure
Regulation Description
Positive end expiratory pressure breathing attachment.
Product Code
BYE
Regulation Number
868.5965
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
5
5
2021
4
4
2022
10
10
2023
8
8
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Gas/Air Leak
5
5
Defective Component
4
4
Detachment of Device or Device Component
3
3
Human-Device Interface Problem
2
2
Key or Button Unresponsive/not Working
2
2
Physical Resistance/Sticking
2
2
Separation Problem
2
2
Disconnection
2
2
Use of Device Problem
2
2
Loose or Intermittent Connection
2
2
Fracture
1
1
Component Missing
1
1
No Pressure
1
1
Connection Problem
1
1
Material Separation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Pressure Problem
1
1
Volume Accuracy Problem
1
1
Difficult to Remove
1
1
Obstruction of Flow
1
1
Inaccurate Flow Rate
1
1
Output above Specifications
1
1
Expiration Date Error
1
1
Gas Output Problem
1
1
Material Integrity Problem
1
1
Difficult to Insert
1
1
Misconnection
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fitting Problem
1
1
Device Difficult to Maintain
1
1
Mechanical Problem
1
1
Blocked Connection
1
1
Tidal Volume Fluctuations
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
Insufficient Information
5
5
Respiratory Insufficiency
4
4
No Consequences Or Impact To Patient
4
4
Unintended Extubation
3
3
Low Oxygen Saturation
1
1
Overinflation of Lung
1
1
No Known Impact Or Consequence To Patient
1
1
Cardiac Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Westmed, Inc.
II
Jun-26-2020
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