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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 111 111
2024 395 396
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 113 113
Unintended Movement 73 73
Use of Device Problem 32 32
Pressure Problem 21 21
Inflation Problem 21 21
Activation Problem 19 19
Appropriate Term/Code Not Available 14 14
Insufficient Information 12 12
Sparking 11 11
Mechanical Problem 11 11
Material Too Soft/Flexible 8 9
Component or Accessory Incompatibility 7 7
No Audible Alarm 7 7
Material Frayed 6 6
Defective Alarm 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Patient Device Interaction Problem 6 6
Decrease in Pressure 5 5
Electrical /Electronic Property Problem 4 4
Material Deformation 4 4
Scratched Material 4 4
Gas/Air Leak 3 3
Deflation Problem 3 3
Break 3 3
Positioning Problem 2 2
Smoking 2 2
Use of Incorrect Control/Treatment Settings 2 2
Unintended Deflation 2 2
Collapse 2 2
Fire 2 2
Battery Problem 1 1
Degraded 1 1
Flare or Flash 1 1
Sharp Edges 1 1
Misassembled 1 1
Material Puncture/Hole 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 1
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 487 488
Insufficient Information 61 61
Pressure Sores 56 56
Erythema 5 5
Fall 5 5
Unspecified Tissue Injury 5 5
Ulcer 4 4
Blister 3 3
Laceration(s) 3 3
Skin Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Hemorrhage/Bleeding 2 2
Cyanosis 1 1
Damage to Ligament(s) 1 1
No Information 1 1
Inflammation 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Depression 1 1
No Patient Involvement 1 1
Pain 1 1
Scar Tissue 1 1
Shock 1 1
Immunodeficiency 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 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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