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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device attachment, breathing, positive end expiratory pressure
Product CodeBYE
Regulation Number 868.5965
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 5 5
2021 4 4
2022 10 10
2023 8 8
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 5 5
Detachment of Device or Device Component 4 4
Defective Component 4 4
Component Missing 2 2
Disconnection 2 2
Loose or Intermittent Connection 2 2
Physical Resistance/Sticking 2 2
Separation Problem 2 2
Key or Button Unresponsive/not Working 2 2
Human-Device Interface Problem 2 2
Output Problem 2 2
Use of Device Problem 2 2
Connection Problem 2 2
Break 1 1
Volume Accuracy Problem 1 1
Fitting Problem 1 1
Pressure Problem 1 1
Material Integrity Problem 1 1
Mechanical Problem 1 1
Misconnection 1 1
Output above Specifications 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
Inaccurate Flow Rate 1 1
Fracture 1 1
Gas Output Problem 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Defective Device 1 1
Blocked Connection 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 5 5
Insufficient Information 5 5
Respiratory Insufficiency 4 4
No Known Impact Or Consequence To Patient 4 4
Unintended Extubation 3 3
Death 1 1
Low Oxygen Saturation 1 1
Overinflation of Lung 1 1
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Westmed, Inc. II Jun-26-2020
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