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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, flotation therapy, non-powered
Regulation Description Nonpowered flotation therapy mattress.
Product CodeIKY
Regulation Number 880.5150
Device Class 1

MDR Year MDR Reports MDR Events
2016 62 62
2017 27 27
2018 130 130
2019 45 102
2020 16 54
2021 12 48

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 139 270
Use of Device Problem 50 50
Maintenance Does Not Comply To Manufacturers Recommendations 47 47
Adverse Event Without Identified Device or Use Problem 30 30
Insufficient Information 11 11
Detachment of Device or Device Component 10 10
Unintended Movement 6 6
Patient Device Interaction Problem 5 5
Patient-Device Incompatibility 5 5
Device Operates Differently Than Expected 5 5
Decrease in Pressure 4 4
Component Falling 4 4
No Apparent Adverse Event 3 3
Structural Problem 3 3
Inflation Problem 2 2
Mechanical Problem 2 2
Detachment Of Device Component 2 2
Device-Device Incompatibility 2 2
Material Deformation 2 2
Pressure Problem 1 1
Leak/Splash 1 1
Inadequacy of Device Shape and/or Size 1 1
Unclear Information 1 1
Air Leak 1 1
Device Emits Odor 1 1
Material Separation 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 1
Break 1 1
Filling Problem 1 1
Fluid Leak 1 1
Kinked 1 1
Loose or Intermittent Connection 1 1
Contamination 1 1
Material Discolored 1 1
Device Contamination with Body Fluid 1 1
Material Integrity Problem 1 1
Device Fell 1 1
Delamination 1 1
Component Missing 1 1
Material Split, Cut or Torn 1 1
Difficult or Delayed Positioning 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 143 143
No Consequences Or Impact To Patient 58 116
Fall 29 40
Pressure Sores 22 22
Injury 13 13
No Clinical Signs, Symptoms or Conditions 8 44
Pain 6 6
Tissue Damage 6 6
Death 5 5
No Patient Involvement 5 41
Physical Entrapment 3 3
Cardiogenic Shock 2 2
Ulcer 2 2
Skin Tears 2 2
No Information 2 2
No Code Available 2 2
Exposure to Body Fluids 2 2
Bruise/Contusion 2 2
Bone Fracture(s) 2 2
Skin Discoloration 2 2
Skin Irritation 1 1
Tinnitus 1 1
Tingling 1 1
Respiratory Distress 1 1
Asphyxia 1 1
Headache 1 1
Hematoma 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Stroke/CVA 1 1
Dyspnea 1 1
Fainting 1 1
Insufficient Information 1 1
Bacterial Infection 1 1
Numbness 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EHOB, Inc. II Jun-24-2021
2 EHOB, Inc. II Mar-09-2020
3 Joerns Healthcare II May-30-2018
4 Stryker Medical Division of Stryker Corporation II Aug-06-2021
5 Stryker Medical Division of Stryker Corporation II Sep-25-2020
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