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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
bed, air fluidized
Product Code
INX
Regulation Number
890.5160
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
10
10
2017
28
28
2018
22
22
2019
15
15
2020
2
2
2021
2
2
2022
18
18
2023
60
60
2024
43
43
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
34
34
Activation Problem
24
24
Device Slipped
19
19
Unintended Movement
18
18
Sparking
15
15
Adverse Event Without Identified Device or Use Problem
9
9
Electrical Power Problem
8
8
Device Displays Incorrect Message
5
5
Material Frayed
5
5
Device Operates Differently Than Expected
5
5
Leak/Splash
4
4
Insufficient Information
4
4
Appropriate Term/Code Not Available
4
4
Arcing
3
3
Electrical Shorting
3
3
Use of Device Problem
3
3
Melted
3
3
Unintended System Motion
3
3
Mechanical Problem
3
3
Device Inoperable
3
3
Smoking
3
3
Loss of Power
2
2
Fail-Safe Design Failure
2
2
Output Problem
2
2
Fire
2
2
Overheating of Device
2
2
Self-Activation or Keying
2
2
Inflation Problem
2
2
Thermal Decomposition of Device
2
2
No Audible Alarm
2
2
Defective Component
2
2
Material Puncture/Hole
2
2
Device Alarm System
2
2
Pressure Problem
2
2
Failure to Deliver
1
1
Deflation Problem
1
1
Decrease in Pressure
1
1
Positioning Problem
1
1
Environmental Compatibility Problem
1
1
Defective Alarm
1
1
Unintended Electrical Shock
1
1
Torn Material
1
1
Noise, Audible
1
1
Component Falling
1
1
Temperature Problem
1
1
Circuit Failure
1
1
Unexpected Shutdown
1
1
Device-Device Incompatibility
1
1
Human-Device Interface Problem
1
1
Air Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
109
109
No Known Impact Or Consequence To Patient
23
23
Pressure Sores
20
20
No Patient Involvement
17
17
Injury
7
7
Insufficient Information
6
6
No Consequences Or Impact To Patient
4
4
Fall
3
3
No Information
2
2
Skin Erosion
2
2
Pain
2
2
Unspecified Tissue Injury
2
2
Electric Shock
1
1
Brain Injury
1
1
No Code Available
1
1
Bone Fracture(s)
1
1
Crushing Injury
1
1
Foreign Body In Patient
1
1
Concussion
1
1
Shock
1
1
-
-