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TPLC
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show TPLC since
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Device
bed, flotation therapy, powered
Regulation Description
Powered flotation therapy bed.
Product Code
IOQ
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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