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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, flotation therapy, powered
Regulation Description Powered flotation therapy bed.
Product CodeIOQ
Regulation Number 890.5170
Device Class 2

MDR Year MDR Reports MDR Events
2021 56 56
2022 22 22
2023 111 114
2024 392 394
2025 143 143
2026 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 190 190
Unintended Movement 87 90
Activation Problem 39 39
Use of Device Problem 31 31
Positioning Failure 26 26
Inflation Problem 21 21
Pressure Problem 21 21
Appropriate Term/Code Not Available 14 14
Insufficient Information 12 12
Sparking 12 13
Mechanical Problem 11 11
No Audible Alarm 8 8
Material Too Soft/Flexible 8 9
Component or Accessory Incompatibility 7 7
Material Frayed 6 7
Adverse Event Without Identified Device or Use Problem 6 6
Electrical /Electronic Property Problem 6 6
Defective Alarm 5 5
Scratched Material 4 4
Material Deformation 4 4
Patient Device Interaction Problem 4 4
Degraded 3 3
Gas/Air Leak 3 3
Break 3 3
Collapse 3 3
Use of Incorrect Control/Treatment Settings 2 2
Deflation Problem 2 2
Fire 2 2
Positioning Problem 2 2
Unintended Deflation 2 4
Sharp Edges 1 1
Complete Loss of Power 1 1
Activation Failure 1 1
Power Problem 1 1
Temperature Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Grounding Malfunction 1 1
Connection Problem 1 1
Flare or Flash 1 1
Device Alarm System 1 1
Misassembled 1 1
Decrease in Pressure 1 1
Material Separation 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 2
No Audible Prompt/Feedback 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 632 637
Insufficient Information 61 61
Pressure Sores 52 52
Fall 6 6
Erythema 5 5
Unspecified Tissue Injury 5 5
Ulcer 4 4
Blister 3 3
Skin Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Laceration(s) 2 2
Cyanosis 1 1
Damage to Ligament(s) 1 1
Bone Fracture(s) 1 1
Inflammation 1 1
Cardiac Arrest 1 1
Needle Stick/Puncture 1 1
Depression 1 1
Pain 1 1
Scar Tissue 1 1
Shock 1 1
Immunodeficiency 1 1
Low Oxygen Saturation 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-26-2025
2 Baxter Healthcare Corporation II Jun-14-2024
3 Baxter Healthcare Corporation II Mar-29-2024
4 Baxter Healthcare Corporation II Nov-02-2023
5 Baxter Healthcare Corporation II May-01-2023
6 Baxter Healthcare Corporation II Jul-20-2022
7 Baxter Healthcare Corporation II Mar-23-2022
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