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TPLC
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show TPLC since
2009
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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
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
256
256
Material Split, Cut or Torn
29
29
Mechanical Problem
28
28
Device Operates Differently Than Expected
22
22
Unintended Movement
21
21
Activation Problem
19
19
Device Inoperable
14
14
Adverse Event Without Identified Device or Use Problem
13
13
Sparking
12
12
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
Unintended System Motion
4
4
Device Emits Odor
4
4
Loose or Intermittent Connection
3
3
Overheating of Device
3
3
Noise, Audible
3
3
Material Frayed
3
3
Melted
3
3
Appropriate Term/Code Not Available
3
3
Inflation Problem
3
3
Fire
3
3
Defective Component
3
3
Improper or Incorrect Procedure or Method
2
2
Unexpected Therapeutic Results
2
2
Bent
2
2
No Audible Alarm
2
2
Material Puncture/Hole
2
2
Self-Activation or Keying
2
2
Unintended Head Motion
2
2
Display or Visual Feedback Problem
2
2
Collapse
2
2
Improper Flow or Infusion
2
2
Output Problem
2
2
Mechanics Altered
2
2
Thermal Decomposition of Device
2
2
Pressure Problem
2
2
Electrical Shorting
2
2
Detachment Of Device Component
2
2
Fail-Safe Design Failure
2
2
Incorrect Device Or Component Shipped
1
1
Device-Device Incompatibility
1
1
Sticking
1
1
Device Contamination with Chemical or Other Material
1
1
Arcing
1
1
Decrease in Pressure
1
1
Material Separation
1
1
Hole In Material
1
1
Material Protrusion/Extrusion
1
1
Inadequate or Insufficient Training
1
1
Environmental Compatibility Problem
1
1
Unexpected Shutdown
1
1
Device Issue
1
1
Air Leak
1
1
Electromagnetic Interference
1
1
Component Falling
1
1
Defective Alarm
1
1
Material Rupture
1
1
Malfunction
1
1
Positioning Problem
1
1
Moisture or Humidity Problem
1
1
Naturally Worn
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Crack
1
1
Difficult To Position
1
1
Temperature Problem
1
1
Defective Device
1
1
Torn Material
1
1
Electrical /Electronic Property Problem
1
1
Circuit Failure
1
1
Deflation Problem
1
1
Particulates
1
1
Component Missing
1
1
Failure to Deliver
1
1
Unintended Electrical Shock
1
1
Human-Device Interface Problem
1
1
Electronic Property Issue
1
1
Flare or Flash
1
1
Ambient Temperature Problem
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
217
217
No Consequences Or Impact To Patient
102
102
No Clinical Signs, Symptoms or Conditions
90
90
Pressure Sores
31
31
No Patient Involvement
18
18
Injury
14
14
Fall
11
11
Therapeutic Response, Decreased
6
6
Insufficient Information
6
6
No Information
5
5
Pain
4
4
Death
3
3
Skin Erosion
2
2
Therapeutic Effects, Unexpected
2
2
Abrasion
2
2
Impaired Healing
2
2
Electric Shock
2
2
Unspecified Tissue Injury
2
2
Skin Tears
1
1
Discomfort
1
1
No Code Available
1
1
Tissue Breakdown
1
1
Foreign Body In Patient
1
1
Burn(s)
1
1
Crushing Injury
1
1
Shock
1
1
Bone Fracture(s)
1
1
Incontinence
1
1
Laceration(s)
1
1
Myocardial Infarction
1
1
Necrosis
1
1
Tissue Damage
1
1
Concussion
1
1
Swelling
1
1
Brain Injury
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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