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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mattress, air flotation, alternating pressure
Product CodeFNM
Regulation Number 880.5550
Device Class 2

MDR Year MDR Reports MDR Events
2014 80 80
2015 80 80
2016 50 50
2017 56 56
2018 115 115
2019 101 101
2020 58 58
2021 47 47
2022 75 75
2023 197 197
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 264 264
Insufficient Information 100 100
Deflation Problem 66 66
Inflation Problem 48 48
Use of Device Problem 37 37
Sparking 25 25
Dent in Material 21 21
Decrease in Pressure 20 20
Increase in Pressure 19 19
Appropriate Term/Code Not Available 18 18
Electrical /Electronic Property Problem 17 17
Device Operates Differently Than Expected 15 15
No Apparent Adverse Event 14 14
Unintended Deflation 13 13
Electrical Shorting 13 13
Fire 13 13
Thermal Decomposition of Device 12 12
Device Inoperable 12 12
Patient-Device Incompatibility 12 12
Failure to Power Up 11 11
Air Leak 11 11
Improper or Incorrect Procedure or Method 9 9
No Pressure 9 9
Pressure Problem 9 9
Device Handling Problem 8 8
Detachment of Device or Device Component 8 8
Device Slipped 8 8
Break 8 8
Product Quality Problem 7 7
Infusion or Flow Problem 7 7
Unintended Electrical Shock 7 7
Installation-Related Problem 6 6
Human Factors Issue 6 6
Improper Flow or Infusion 6 6
Computer Software Problem 6 6
No Audible Alarm 6 6
Smoking 5 5
Material Separation 5 5
Material Integrity Problem 5 5
Unclear Information 5 5
Patient Device Interaction Problem 4 4
Inadequate or Insufficient Training 4 4
Mechanical Problem 4 4
Component Falling 4 4
Moisture Damage 4 4
Disconnection 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 3 3
Bent 3 3
Use of Incorrect Control/Treatment Settings 3 3
Crack 3 3
Device Alarm System 3 3
Hole In Material 3 3
Material Puncture/Hole 3 3
Off-Label Use 3 3
Defective Component 3 3
Device Issue 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 3 3
Device-Device Incompatibility 3 3
Device Operational Issue 3 3
Structural Problem 3 3
Device Displays Incorrect Message 2 2
Malposition of Device 2 2
Defective Device 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Gas/Air Leak 2 2
Material Deformation 2 2
Positioning Problem 2 2
Power Problem 2 2
Scratched Material 2 2
Unintended Movement 2 2
Complete Loss of Power 2 2
Material Split, Cut or Torn 2 2
Sharp Edges 2 2
Overfill 2 2
Component Missing 2 2
Self-Activation or Keying 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Failure to Pump 2 2
Loss of Power 2 2
Peeled/Delaminated 2 2
Defective Alarm 2 2
Burst Container or Vessel 2 2
Circuit Failure 2 2
Filling Problem 2 2
Unintended System Motion 2 2
Energy Output Problem 1 1
Overheating of Device 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Device Maintenance Issue 1 1
Fluid/Blood Leak 1 1
Material Frayed 1 1
Material Discolored 1 1
Fail-Safe Design Failure 1 1
Complete Blockage 1 1
Collapse 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 320 320
Pressure Sores 143 143
No Consequences Or Impact To Patient 87 87
No Clinical Signs, Symptoms or Conditions 68 68
No Known Impact Or Consequence To Patient 52 52
Tissue Breakdown 33 33
Death 26 27
Pain 26 26
Injury 24 24
Insufficient Information 20 20
Bruise/Contusion 20 20
Electric Shock 17 17
Bone Fracture(s) 17 17
Ulcer 16 16
No Information 16 16
No Patient Involvement 15 15
Physical Entrapment 13 14
Laceration(s) 12 12
Skin Tears 12 12
Head Injury 10 10
Burn(s) 9 9
Hematoma 8 8
Discomfort 7 7
Contusion 6 6
Hip Fracture 6 6
Localized Skin Lesion 5 5
Abrasion 5 5
Tissue Damage 4 4
Pleural Effusion 4 4
Skin Erosion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Ulceration 3 3
Blister 3 3
Joint Dislocation 3 3
Skin Discoloration 2 2
Skull Fracture 2 2
Exposure to Body Fluids 2 2
Impaired Healing 2 2
Skin Infection 2 2
No Code Available 2 2
Vertebral Fracture 2 2
Fungal Infection 2 2
Swelling/ Edema 2 2
Necrosis 1 1
Local Reaction 1 1
Skin Inflammation/ Irritation 1 1
Strangulation 1 1
Gangrene 1 1
Fracture, Arm 1 1
Cardiopulmonary Arrest 1 1
Neck Pain 1 1
Acoustic Shock 1 1
Multiple Fractures 1 1
Cardiac Arrest 1 1
Pneumonia 1 1
Burn, Thermal 1 1
Headache 1 1
Brain Injury 1 1
Abdominal Pain 1 1
Asphyxia 1 1
Unspecified Tissue Injury 1 1
Swelling 1 1
Eye Injury 1 1
Reaction 1 1
Complaint, Ill-Defined 1 1
Limb Fracture 1 1
Fatigue 1 1
Superficial (First Degree) Burn 1 1
Contact Dermatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American National Mfg Inc II Aug-19-2016
2 Encompass Therapeutic Support Systems dba BG North America II Mar-31-2010
3 Getinge (Suzhou) Co Ltd II Jun-04-2021
4 Hill-Rom Manufacturing, Inc. II Jan-07-2009
5 SCM True Air Technologies LLC II May-19-2014
6 Stryker Medical Division of Stryker Corporation II Mar-08-2016
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