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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


Premarket Reviews
ManufacturerDecision
REVOLUTIONARY MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 6 6
2019 11 11
2020 1 1
2021 10 10
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 6 6
Gas Leak 6 6
Defective Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient-Device Incompatibility 2 2
Break 2 2
Intermittent Continuity 1 1
Crack 1 1
Deflation Problem 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Gas Output Problem 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Failure to Transmit Record 1 1
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1
Device Fell 1 1
Failure to Deliver 1 1
Defective Device 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 7 7
No Patient Involvement 3 3
Respiratory Distress Syndrome of Newborns 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Blister 2 2
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Insufficient Information 1 1
Skin Erosion 1 1
Tissue Damage 1 1
No Information 1 1

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