Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
mask, gas, anesthetic
Product Code
BSJ
Regulation Number
868.5550
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
-
-