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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, gas, anesthetic
Product CodeBSJ
Regulation Number 868.5550
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 11 11
2022 11 11
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 5 5
Material Puncture/Hole 3 3
Gas/Air Leak 3 3
Inflation Problem 3 3
Leak/Splash 2 2
Patient-Device Incompatibility 2 2
Unintended Deflation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unexpected Color 2 2
Break 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Filtration Problem 1 1
Filling Problem 1 1
Defective Device 1 1
Deflation Problem 1 1
Failure to Deliver 1 1
Material Discolored 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Intermittent Continuity 1 1
Human-Device Interface Problem 1 1
Gas Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Respiratory Distress Syndrome of Newborns 3 3
Blister 2 2
Insufficient Information 2 2
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1

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