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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, air fluidized
Product CodeINX
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
Device Operates Differently Than Expected 22 22
Unintended Movement 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
Electrical Power Problem 8 8
Insufficient Information 8 8
Use of Device Problem 7 7
Break 6 6
Device Alarm System 6 6
Material Frayed 5 5
Loss of Power 5 5
Smoking 5 5
Unintended System Motion 4 4
Appropriate Term/Code Not Available 4 4
Device Emits Odor 4 4
Noise, Audible 3 3
Arcing 3 3
Loose or Intermittent Connection 3 3
Overheating of Device 3 3
Melted 3 3
Electrical Shorting 3 3
Inflation Problem 3 3
Thermal Decomposition of Device 3 3
Fire 3 3
Defective Component 3 3
Fail-Safe Design Failure 2 2
Detachment Of Device Component 2 2
Improper Flow or Infusion 2 2
No Audible Alarm 2 2
Pressure Problem 2 2
Mechanics Altered 2 2
Improper or Incorrect Procedure or Method 2 2
Bent 2 2
Display or Visual Feedback Problem 2 2
Output Problem 2 2
Self-Activation or Keying 2 2
Unexpected Therapeutic Results 2 2
Material Puncture/Hole 2 2
Collapse 2 2
Unintended Head Motion 2 2
Circuit Failure 1 1
Temperature Problem 1 1
Hole In Material 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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