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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, oxygen
Product CodeBYG
Regulation Number 868.5580
Device Class 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 6 6
2021 12 12
2022 18 18
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 9 9
Detachment of Device or Device Component 8 8
Disconnection 6 6
Material Deformation 5 5
Loose or Intermittent Connection 4 4
Break 3 3
Fracture 2 2
Defective Component 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Material Separation 2 2
Failure to Unfold or Unwrap 2 2
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 2 2
Contamination /Decontamination Problem 2 2
Failure to Seal 2 2
Incomplete or Inadequate Connection 1 1
Material Too Soft/Flexible 1 1
Fitting Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Patient-Device Incompatibility 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Device Alarm System 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Use of Incorrect Control/Treatment Settings 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Consequences Or Impact To Patient 16 16
Low Oxygen Saturation 9 9
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 4 4
Tissue Breakdown 3 3
No Patient Involvement 2 2
Skin Inflammation/ Irritation 2 2
Respiratory Insufficiency 2 2
Blister 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Loss of consciousness 1 1
Choking 1 1
Abnormal Blood Gases 1 1
Corneal Abrasion 1 1
Cyanosis 1 1
Dyspnea 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 POM Medical LLC II Oct-31-2019
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