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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 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 194 194
Unintended Movement 88 91
Activation Problem 40 40
Positioning Failure 40 40
Use of Device Problem 32 32
Pressure Problem 21 21
Inflation Problem 20 20
Appropriate Device Problem Term/Code Not Available 14 14
Insufficient Device Problem Information 13 13
Sparking 12 12
Mechanical Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Material Too Soft/Flexible 8 9
No Audible Alarm 8 8
Component or Accessory Incompatibility 7 7
Electrical /Electronic Property Problem 6 6
Defective Alarm 5 5
Material Frayed 5 5
Material Deformation 4 4
Scratched Material 4 4
Patient Device Interaction Problem 3 3
Collapse 3 3
Flare or Flash 2 2
Use of Incorrect Control/Treatment Settings 2 2
Unintended Deflation 2 4
Positioning Problem 2 2
Fire 2 2
Break 2 2
Gas/Air Leak 2 2
Decrease in Pressure 1 1
Connection Problem 1 1
No Audible Prompt/Feedback 1 1
Power Problem 1 1
Material Protrusion/Extrusion 1 1
Degraded 1 1
Naturally Worn 1 1
Activation Failure 1 1
Mechanical Jam 1 1
Smoking 1 1
Grounding Malfunction 1 1
Misassembled 1 1
Complete Loss of Power 1 1
Deflation Problem 1 1
Device Alarm System 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 659 664
Insufficient Information 61 61
Pressure Sore/Ulcer 53 53
Unspecified Tissue Injury 6 6
Fall 6 6
Erythema 5 5
Ulcer 4 4
Blister 3 3
Skin Infection 2 2
Electric Shock 2 2
Laceration(s) 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Cyanosis 1 1
Needle Stick/Puncture 1 1
Immunodeficiency 1 1
Damage to Ligament(s) 1 1
Bone Fracture(s) 1 1
Pain 1 1
Scar Tissue 1 1
Low Oxygen Saturation 1 1
Inflammation 1 1
Device Embedded In Tissue or Plaque 1 1
Shock 1 1
Cardiac Arrest 1 1
Depression 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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