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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
2014 12 12
2016 4 4
2018 6 6
2019 11 11
2020 1 1
2021 11 11
2022 11 11
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 8 8
Gas/Air Leak 7 7
Material Deformation 6 6
Inflation Problem 6 6
Break 4 4
Detachment Of Device Component 2 2
Defective Component 2 2
Material Puncture/Hole 2 2
Leak/Splash 2 2
Deflation Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Unexpected Color 2 2
Unintended Deflation 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Markings/Labelling Problem 1 1
Filtration Problem 1 1
Operating System Becomes Nonfunctional 1 1
Pressure Problem 1 1
Torn Material 1 1
Device Fell 1 1
Material Discolored 1 1
Filling Problem 1 1
Unintended Ejection 1 1
Gas Output Problem 1 1
Hole In Material 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1
Failure to Deliver 1 1
Intermittent Continuity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 11 11
Respiratory Distress Syndrome of Newborns 3 3
No Patient Involvement 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Low Oxygen Saturation 2 2
Not Applicable 2 2
No Information 2 2
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
Apnea 1 1
Bradycardia 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Engineered Medical Systems,Inc I Apr-10-2013
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