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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
2020 9 9
2021 56 56
2022 22 22
2023 111 114
2024 392 394
2025 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 168 168
Unintended Movement 78 81
Activation Problem 35 35
Use of Device Problem 31 31
Pressure Problem 21 21
Inflation Problem 21 21
Appropriate Term/Code Not Available 14 14
Sparking 12 13
Mechanical Problem 12 12
Insufficient Information 12 12
Material Too Soft/Flexible 8 9
Component or Accessory Incompatibility 7 7
No Audible Alarm 7 7
Material Frayed 6 7
Defective Alarm 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Electrical /Electronic Property Problem 5 5
Decrease in Pressure 5 5
Material Deformation 4 4
Scratched Material 4 4
Patient Device Interaction Problem 4 4
Gas/Air Leak 3 3
Degraded 3 3
Deflation Problem 3 3
Collapse 3 3
Break 3 3
Positioning Problem 2 2
Smoking 2 2
Use of Incorrect Control/Treatment Settings 2 2
Unintended Deflation 2 4
Fire 2 2
Battery Problem 1 1
Flare or Flash 1 1
Defective Device 1 1
Sharp Edges 1 1
Misassembled 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Power Problem 1 1
Device Alarm System 1 1
Grounding Malfunction 1 1
Connection Problem 1 1
Naturally Worn 1 1
Complete Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 2
Mechanical Jam 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 569 574
Insufficient Information 61 61
Pressure Sores 56 56
Fall 6 6
Erythema 5 5
Unspecified Tissue Injury 5 5
Ulcer 4 4
Blister 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Skin Infection 2 2
Electric Shock 2 2
Laceration(s) 2 2
Damage to Ligament(s) 1 1
Cyanosis 1 1
No Information 1 1
Inflammation 1 1
No Known Impact Or Consequence To Patient 1 1
Cardiac Arrest 1 1
Injury 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Depression 1 1
Scar Tissue 1 1
Pain 1 1
Shock 1 1
Immunodeficiency 1 1
No Consequences Or Impact To Patient 1 1
Tissue Breakdown 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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