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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
bed, patient rotation, powered
Product Code
IKZ
Regulation Number
890.5225
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
28
28
2019
27
27
2020
29
29
2021
11
11
2022
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
37
37
Difficult to Open or Close
13
13
Insufficient Information
11
11
Electrical /Electronic Property Problem
5
5
Use of Device Problem
4
4
Material Too Soft/Flexible
3
3
No Apparent Adverse Event
3
3
Mechanical Problem
3
3
Patient-Device Incompatibility
3
3
Mechanical Jam
2
2
Patient Device Interaction Problem
2
2
Product Quality Problem
2
2
Defective Component
2
2
Unintended Movement
2
2
Sharp Edges
2
2
Difficult or Delayed Positioning
2
2
Misassembly During Maintenance/Repair
1
1
Device Alarm System
1
1
Component Falling
1
1
Device Difficult to Program or Calibrate
1
1
Self-Activation or Keying
1
1
Manufacturing, Packaging or Shipping Problem
1
1
No Device Output
1
1
Difficult To Position
1
1
Device Slipped
1
1
Break
1
1
Crack
1
1
No Display/Image
1
1
Unintended Ejection
1
1
Intermittent Energy Output
1
1
Defective Device
1
1
Output Problem
1
1
Physical Resistance/Sticking
1
1
Pressure Problem
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Unclear Information
1
1
Operating System Becomes Nonfunctional
1
1
Fire
1
1
Failure to Power Up
1
1
Device Issue
1
1
Device Operates Differently Than Expected
1
1
Human Factors Issue
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pressure Sores
40
40
No Consequences Or Impact To Patient
18
18
Injury
11
11
No Clinical Signs, Symptoms or Conditions
7
7
No Known Impact Or Consequence To Patient
7
7
Tissue Breakdown
4
4
Tissue Damage
4
4
Pain
3
3
Death
2
2
Physical Entrapment
2
2
Low Oxygen Saturation
2
2
Fall
1
1
Extubate
1
1
Bone Fracture(s)
1
1
Necrosis
1
1
No Code Available
1
1
Scar Tissue
1
1
Laceration(s)
1
1
Unintended Extubation
1
1
Insufficient Information
1
1
Cardiopulmonary Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arjohuntleigh Magog
II
Feb-05-2019
2
Kinsman Enterprises Inc
II
Oct-21-2021
3
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
-
-