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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, oxygen, non-rebreathing
Product CodeKGB
Regulation Number 868.5570
Device Class 1

MDR Year MDR Reports MDR Events
2014 32 32
2015 53 53
2016 22 22
2017 3 3
2018 5 5
2019 1 1
2020 9 9
2022 6 6
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 27 27
Disconnection 23 23
Connection Problem 18 18
Inflation Problem 13 13
Break 9 9
Loose or Intermittent Connection 9 9
Defective Device 6 6
Gas/Air Leak 5 5
Leak/Splash 5 5
Failure To Adhere Or Bond 5 5
Device Damaged Prior to Use 4 4
Hole In Material 4 4
Burst Container or Vessel 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Patient-Device Incompatibility 2 2
Material Separation 2 2
Improper Flow or Infusion 2 2
Fitting Problem 2 2
Material Rupture 2 2
Crack 1 1
Defective Component 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Device Operates Differently Than Expected 1 1
Inaccurate Delivery 1 1
Material Too Rigid or Stiff 1 1
Occlusion Within Device 1 1
Device Slipped 1 1
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Decrease in Pressure 1 1
Device Displays Incorrect Message 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 75 75
No Consequences Or Impact To Patient 17 17
Low Oxygen Saturation 10 10
No Patient Involvement 8 8
Respiratory Distress 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Death 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dizziness 2 2
Insufficient Information 2 2
Pressure Sores 2 2
Headache 2 2
Adult Respiratory Distress Syndrome 1 1
Aspiration/Inhalation 1 1
Confusion/ Disorientation 1 1
Foreign Body In Patient 1 1
Shock 1 1
Hypoxia 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Westmed, Inc. II Dec-29-2020
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