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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 10 10
Inflation Problem 9 9
Disconnection 6 6
Material Deformation 5 5
Loose or Intermittent Connection 4 4
Material Split, Cut or Torn 4 4
Break 3 3
Failure to Seal 2 2
Fracture 2 2
Defective Component 2 2
Material Integrity Problem 2 2
Contamination /Decontamination Problem 2 2
Patient Device Interaction Problem 2 2
Failure to Unfold or Unwrap 2 2
Material Separation 2 2
Material Twisted/Bent 2 2
Display or Visual Feedback Problem 1 1
Difficult to Open or Close 1 1
Material Too Soft/Flexible 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Failure to Calibrate 1 1
Inaccurate Delivery 1 1
Electrical Shorting 1 1
Labelling, Instructions for Use or Training Problem 1 1
Delivered as Unsterile Product 1 1
Use of Incorrect Control/Treatment Settings 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Infusion or Flow Problem 1 1
Improper Flow or Infusion 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Unsealed Device Packaging 1 1
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Device Markings/Labelling Problem 1 1
Device Alarm System 1 1
Incomplete or Inadequate Connection 1 1
Output Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Fitting Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 16 16
No Known Impact Or Consequence To Patient 9 9
Low Oxygen Saturation 9 9
Insufficient Information 4 4
Tissue Breakdown 3 3
Skin Inflammation/ Irritation 2 2
No Patient Involvement 2 2
Hypoxia 2 2
Respiratory Insufficiency 2 2
Cyanosis 1 1
Complaint, Ill-Defined 1 1
Abnormal Blood Gases 1 1
Corneal Abrasion 1 1
Blister 1 1
Confusion/ Disorientation 1 1
Discomfort 1 1
Dyspnea 1 1
Choking 1 1
Loss of consciousness 1 1
Lethargy 1 1

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