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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 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 269 269
Insufficient Information 100 100
Deflation Problem 70 70
Inflation Problem 48 48
Use of Device Problem 38 38
Sparking 29 29
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
Infusion or Flow Problem 8 8
Device Slipped 8 8
Break 8 8
Product Quality 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
Malposition of Device 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
Self-Activation or Keying 3 3
Defective Component 3 3
Device Issue 3 3
Structural Problem 3 3
Device Operational Issue 3 3
Device-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 3 3
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
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Device Displays Incorrect Message 2 2
Defective Device 2 2
Overfill 2 2
Component Missing 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 321 321
Pressure Sores 154 154
No Consequences Or Impact To Patient 87 87
No Clinical Signs, Symptoms or Conditions 74 74
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
Bone Fracture(s) 17 17
Ulcer 17 17
Electric Shock 17 17
No Information 16 16
No Patient Involvement 15 15
Physical Entrapment 13 14
Skin Tears 12 12
Laceration(s) 12 12
Head Injury 10 10
Burn(s) 9 9
Hematoma 8 8
Discomfort 7 7
Hip Fracture 6 6
Contusion 6 6
Abrasion 5 5
Localized Skin Lesion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tissue Damage 4 4
Skin Erosion 4 4
Pleural Effusion 4 4
Ulceration 3 3
Blister 3 3
Joint Dislocation 3 3
Impaired Healing 2 2
Fungal Infection 2 2
Swelling/ Edema 2 2
Skin Infection 2 2
No Code Available 2 2
Vertebral Fracture 2 2
Skin Discoloration 2 2
Skull Fracture 2 2
Exposure to Body Fluids 2 2
Abdominal Pain 1 1
Acoustic Shock 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Headache 1 1
Gangrene 1 1
Eye Injury 1 1
Fatigue 1 1
Asphyxia 1 1
Strangulation 1 1
Swelling 1 1
Pneumonia 1 1
Local Reaction 1 1
Unspecified Infection 1 1
Necrosis 1 1
Superficial (First Degree) Burn 1 1
Limb Fracture 1 1
Multiple Fractures 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Neck Pain 1 1
Reaction 1 1
Burn, Thermal 1 1
Fracture, Arm 1 1
Brain Injury 1 1
Complaint, Ill-Defined 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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