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
Premarket Reviews
Manufacturer
Decision
HILL-ROM
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
35
35
2015
27
27
2016
42
42
2017
22
22
2018
20
20
2019
4
4
2020
9
9
2021
56
56
2022
22
22
2023
111
111
2024
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
52
52
Material Split, Cut or Torn
35
35
Use of Device Problem
35
35
Insufficient Information
31
31
Inflation Problem
25
25
Adverse Event Without Identified Device or Use Problem
23
23
Pressure Problem
22
22
Device Slipped
22
22
Mechanical Problem
16
16
Appropriate Term/Code Not Available
13
13
Sparking
11
11
Activation Problem
11
11
Device Operates Differently Than Expected
8
8
Device Inoperable
8
8
Component or Accessory Incompatibility
7
7
Defective Alarm
7
7
No Audible Alarm
7
7
Break
7
7
Unintended Head Motion
6
6
Material Frayed
5
5
Device Alarm System
5
5
Smoking
5
5
Decrease in Pressure
5
5
Material Deformation
5
5
Scratched Material
4
4
Improper or Incorrect Procedure or Method
4
4
Electrical /Electronic Property Problem
4
4
Patient Device Interaction Problem
4
4
Use of Incorrect Control/Treatment Settings
3
3
Deflation Problem
3
3
Detachment Of Device Component
3
3
Device Displays Incorrect Message
3
3
Defective Device
3
3
Temperature Problem
3
3
Gas/Air Leak
3
3
Positioning Problem
2
2
Power Problem
2
2
Material Integrity Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Defective Component
2
2
Connection Problem
2
2
Patient-Device Incompatibility
2
2
Collapse
2
2
Thermal Decomposition of Device
2
2
Fail-Safe Design Failure
2
2
Fire
2
2
Sticking
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Unintended Deflation
2
2
Sharp Edges
1
1
Complete Loss of Power
1
1
No Apparent Adverse Event
1
1
Inadequacy of Device Shape and/or Size
1
1
Increase in Pressure
1
1
Material Puncture/Hole
1
1
Failure to Reset
1
1
Misassembled
1
1
Device Emits Odor
1
1
Loss of Power
1
1
Excess Flow or Over-Infusion
1
1
Difficult to Insert
1
1
Device Maintenance Issue
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Grounding Malfunction
1
1
Device Reprocessing Problem
1
1
Failure To Adhere Or Bond
1
1
Component Falling
1
1
Battery Problem
1
1
Malposition of Device
1
1
Device Operational Issue
1
1
Arcing
1
1
Device Tipped Over
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
Improper Device Output
1
1
Installation-Related Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
131
131
Pressure Sores
70
70
No Known Impact Or Consequence To Patient
52
52
Insufficient Information
28
28
Fall
19
19
No Consequences Or Impact To Patient
16
16
Injury
15
15
Tissue Breakdown
14
14
Erythema
6
6
No Information
6
6
Electric Shock
5
5
No Patient Involvement
4
4
Ulcer
4
4
No Code Available
4
4
Unspecified Tissue Injury
4
4
Blister
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Death
2
2
Swelling
2
2
Bone Fracture(s)
2
2
Head Injury
2
2
Wound Dehiscence
2
2
Pain
2
2
Respiratory Distress
1
1
Scar Tissue
1
1
Shock
1
1
Skin Erosion
1
1
Spinal Column Injury
1
1
Bacterial Infection
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Contusion
1
1
Cyanosis
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Laceration(s)
1
1
Damage to Ligament(s)
1
1
Tissue Damage
1
1
Therapeutic Response, Decreased
1
1
Physical Entrapment
1
1
Discomfort
1
1
Device Embedded In Tissue or Plaque
1
1
Hip Fracture
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Mar-29-2024
2
Baxter Healthcare Corporation
II
Nov-02-2023
3
Baxter Healthcare Corporation
II
May-01-2023
4
Baxter Healthcare Corporation
II
Jul-20-2022
5
Baxter Healthcare Corporation
II
Mar-23-2022
6
Hill-Rom Manufacturing, Inc.
II
Feb-15-2011
7
Hill-Rom Manufacturing, Inc.
II
Aug-03-2009
8
Hill-Rom, Inc.
II
Jul-23-2013
9
Hill-Rom, Inc.
II
Mar-14-2013
10
KCI USA, Inc.
II
Nov-20-2012
11
KCI USA, Inc.
II
Jan-25-2010
12
Stryker Medical Division of Stryker Corporation
II
Sep-15-2018
13
Stryker Medical Division of Stryker Corporation
II
Aug-09-2013
-
-