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TPLC
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show TPLC since
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Device
bed, air fluidized
Regulation Description
Air-fluidized bed.
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Brake
25
25
Device Slipped
19
19
Adverse Event Without Identified Device or Use Problem
8
8
Device Displays Incorrect Message
5
5
Device Operates Differently Than Expected
5
5
Insufficient Information
4
4
Unintended Movement
4
4
Device Inoperable
3
3
Leak/Splash
3
3
Unintended System Motion
3
3
Self-Activation or Keying
2
2
Device Alarm System
2
2
Fail-Safe Design Failure
2
2
Defective Component
2
2
Pressure Problem
2
2
Inflation Problem
2
2
Mechanical Problem
2
2
Fire
2
2
Loss of Power
2
2
Use of Device Problem
2
2
Failure to Deliver
1
1
Device Issue
1
1
Sparking
1
1
Manifold
1
1
Unintended Head Motion
1
1
Overheating of Device
1
1
Difficult To Position
1
1
Heads
1
1
Air Leak
1
1
Deflation Problem
1
1
Display or Visual Feedback Problem
1
1
Material Split, Cut or Torn
1
1
Smoking
1
1
Environmental Compatibility Problem
1
1
Human-Device Interface Problem
1
1
Improper Flow or Infusion
1
1
Temperature Problem
1
1
Torn Material
1
1
Improper or Incorrect Procedure or Method
1
1
Device-Device Incompatibility
1
1
Electronic Property Issue
1
1
Positioning Problem
1
1
Defective Alarm
1
1
Circuit Failure
1
1
Component Falling
1
1
Electrical /Electronic Property Problem
1
1
Alarm
1
1
Wire
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
23
23
No Patient Involvement
17
17
Pressure Sores
16
16
Injury
7
7
No Consequences Or Impact To Patient
4
4
Fall
2
2
Skin Erosion
2
2
Pain
2
2
No Information
2
2
No Code Available
1
1
Shock
1
1
Brain Injury
1
1
Bone Fracture(s)
1
1
Concussion
1
1
Crushing Injury
1
1
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