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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
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2024
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Device
bed, air fluidized
Product Code
INX
Regulation Number
890.5160
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
282
282
2015
51
51
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
Device Slipped
256
256
Material Split, Cut or Torn
34
34
Mechanical Problem
28
28
Activation Problem
24
24
Unintended Movement
22
22
Device Operates Differently Than Expected
22
22
Sparking
16
16
Device Inoperable
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Device Displays Incorrect Message
10
10
Leak/Splash
9
9
Insufficient Information
8
8
Electrical Power Problem
8
8
Use of Device Problem
7
7
Break
6
6
Device Alarm System
6
6
Loss of Power
5
5
Smoking
5
5
Material Frayed
5
5
Device Emits Odor
4
4
Appropriate Term/Code Not Available
4
4
Unintended System Motion
4
4
Loose or Intermittent Connection
3
3
Arcing
3
3
Overheating of Device
3
3
Inflation Problem
3
3
Defective Component
3
3
Noise, Audible
3
3
Fire
3
3
Melted
3
3
Electrical Shorting
3
3
Thermal Decomposition of Device
3
3
Unintended Head Motion
2
2
Unexpected Therapeutic Results
2
2
Detachment Of Device Component
2
2
Output Problem
2
2
Display or Visual Feedback Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Pressure Problem
2
2
Self-Activation or Keying
2
2
No Audible Alarm
2
2
Mechanics Altered
2
2
Bent
2
2
Collapse
2
2
Material Puncture/Hole
2
2
Improper Flow or Infusion
2
2
Fail-Safe Design Failure
2
2
Electrical /Electronic Property Problem
1
1
Electronic Property Issue
1
1
Device Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
217
217
No Clinical Signs, Symptoms or Conditions
109
109
No Consequences Or Impact To Patient
102
102
Pressure Sores
32
32
No Patient Involvement
18
18
Injury
14
14
Fall
11
11
Insufficient Information
6
6
Therapeutic Response, Decreased
6
6
No Information
5
5
Pain
4
4
Death
3
3
Impaired Healing
2
2
Electric Shock
2
2
Abrasion
2
2
Skin Erosion
2
2
Unspecified Tissue Injury
2
2
Therapeutic Effects, Unexpected
2
2
Brain Injury
1
1
No Code Available
1
1
Necrosis
1
1
Bone Fracture(s)
1
1
Crushing Injury
1
1
Incontinence
1
1
Burn(s)
1
1
Foreign Body In Patient
1
1
Discomfort
1
1
Swelling
1
1
Concussion
1
1
Laceration(s)
1
1
Shock
1
1
Skin Tears
1
1
Myocardial Infarction
1
1
Tissue Damage
1
1
Tissue Breakdown
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hill-Rom Manufacturing, Inc.
II
Aug-25-2009
2
Hill-Rom, Inc.
III
Mar-01-2012
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