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, manual
Product Code
FNJ
Regulation Number
880.5120
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
20
20
2015
9
9
2016
3
3
2017
8
8
2018
3
3
2019
7
7
2020
4
4
2021
8
8
2022
23
23
2023
60
60
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
41
41
No Audible Alarm
19
19
Material Split, Cut or Torn
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Break
10
10
Activation Problem
8
8
Mechanical Problem
6
6
Device Operates Differently Than Expected
5
5
Appropriate Term/Code Not Available
5
5
Collapse
4
4
Bent
3
3
Component Missing
3
3
Material Frayed
3
3
Device Slipped
3
3
Use of Device Problem
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Installation-Related Problem
2
2
Defective Alarm
2
2
Detachment Of Device Component
2
2
Electrical /Electronic Property Problem
2
2
Entrapment of Device
2
2
Patient Device Interaction Problem
2
2
Insufficient Information
2
2
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Misassembly by Users
1
1
No Apparent Adverse Event
1
1
Positioning Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Fracture
1
1
Charred
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Shipping Damage or Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Component Falling
1
1
Crack
1
1
Material Disintegration
1
1
Device Alarm System
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Naturally Worn
1
1
Defective Device
1
1
Sparking
1
1
Activation, Positioning or Separation Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Smoking
1
1
Hole In Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89
89
No Known Impact Or Consequence To Patient
24
24
Fall
12
12
Laceration(s)
6
6
Physical Entrapment
6
6
Death
5
5
Injury
4
4
No Information
3
3
Bone Fracture(s)
3
3
Bruise/Contusion
2
2
No Consequences Or Impact To Patient
2
2
Pain
2
2
Hip Fracture
2
2
Arthralgia
1
1
Loss of consciousness
1
1
Aortic Dissection
1
1
No Patient Involvement
1
1
No Code Available
1
1
Limb Fracture
1
1
Insufficient Information
1
1
Paralysis
1
1
Spinal Column Injury
1
1
Strangulation
1
1
Suffocation
1
1
Abrasion
1
1
Discomfort
1
1
Cardiac Arrest
1
1
Eye Injury
1
1
Head Injury
1
1
Hematoma
1
1
Asphyxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hill-Rom, Inc.
II
Aug-03-2010
2
Oakworks Inc
II
Jun-06-2022
3
Stryker Medical Div. of Stryker Corporation
II
Sep-01-2010
-
-