Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
bed, flotation therapy, powered
Product Code
IOQ
Regulation Number
890.5170
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
9
9
2021
56
56
2022
22
22
2023
111
111
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
44
44
Material Split, Cut or Torn
29
29
Use of Device Problem
28
28
Inflation Problem
21
21
Pressure Problem
21
21
Appropriate Term/Code Not Available
12
12
Mechanical Problem
11
11
Activation Problem
10
10
Insufficient Information
9
9
Sparking
9
9
Component or Accessory Incompatibility
7
7
Defective Alarm
6
6
No Audible Alarm
5
5
Decrease in Pressure
5
5
Break
4
4
Material Deformation
4
4
Patient Device Interaction Problem
4
4
Scratched Material
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Gas/Air Leak
3
3
Deflation Problem
3
3
Electrical /Electronic Property Problem
3
3
Material Frayed
3
3
Fire
2
2
Collapse
2
2
Use of Incorrect Control/Treatment Settings
2
2
Positioning Problem
2
2
Unintended Deflation
2
2
Sharp Edges
1
1
Complete Loss of Power
1
1
Power Problem
1
1
Temperature Problem
1
1
No Apparent Adverse Event
1
1
Device Alarm System
1
1
Connection Problem
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
Grounding Malfunction
1
1
Material Puncture/Hole
1
1
Smoking
1
1
Misassembled
1
1
Patient-Device Incompatibility
1
1
Battery Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
117
117
Pressure Sores
52
52
Insufficient Information
28
28
Erythema
5
5
Fall
5
5
Ulcer
4
4
Unspecified Tissue Injury
4
4
Blister
3
3
No Known Impact Or Consequence To Patient
2
2
Injury
2
2
Electric Shock
2
2
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Tissue Breakdown
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Inflammation
1
1
Laceration(s)
1
1
Damage to Ligament(s)
1
1
Pain
1
1
Scar Tissue
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Nov-02-2023
2
Baxter Healthcare Corporation
II
May-01-2023
3
Baxter Healthcare Corporation
II
Jul-20-2022
4
Baxter Healthcare Corporation
II
Mar-23-2022
-
-