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TPLC
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show TPLC since
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2024
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Device
bed, patient rotation, powered
Product Code
IKZ
Regulation Number
890.5225
Device Class
2
MDR Year
MDR Reports
MDR Events
2015
40
40
2016
26
26
2017
35
35
2018
28
28
2019
27
27
2020
29
29
2021
11
11
2022
6
6
2023
20
20
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
78
78
Insufficient Information
22
22
Difficult to Open or Close
17
17
Use of Device Problem
16
16
Electrical /Electronic Property Problem
11
11
Break
11
11
Device Handling Problem
9
9
Device Inoperable
8
8
Defective Component
8
8
Device Operates Differently Than Expected
7
7
Mechanical Problem
6
6
Patient Device Interaction Problem
6
6
Unintended System Motion
5
5
Unintended Movement
5
5
Device Displays Incorrect Message
4
4
Detachment Of Device Component
4
4
Human Factors Issue
4
4
No Display/Image
4
4
Patient-Device Incompatibility
4
4
Positioning Problem
4
4
No Apparent Adverse Event
4
4
Device Issue
3
3
Material Too Soft/Flexible
3
3
Sharp Edges
3
3
Cut In Material
3
3
Device Slipped
3
3
Difficult To Position
3
3
Detachment of Device or Device Component
3
3
Loose or Intermittent Connection
2
2
Mechanical Jam
2
2
Human-Device Interface Problem
2
2
Low Audible Alarm
2
2
Device Dislodged or Dislocated
2
2
Deflation Problem
2
2
Scratched Material
2
2
Device Alarm System
2
2
Sticking
2
2
Product Quality Problem
2
2
Material Integrity Problem
2
2
Defective Device
2
2
Difficult or Delayed Positioning
2
2
Inflation Problem
2
2
Material Protrusion/Extrusion
1
1
Device Emits Odor
1
1
Intermittent Energy Output
1
1
Crack
1
1
Smoking
1
1
Separation Failure
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pressure Sores
65
65
No Consequences Or Impact To Patient
37
37
No Known Impact Or Consequence To Patient
29
29
Injury
20
20
No Clinical Signs, Symptoms or Conditions
12
12
Tissue Damage
12
12
Death
11
11
Pain
9
9
Fall
8
8
Low Oxygen Saturation
7
7
No Information
6
6
Tissue Breakdown
6
6
Insufficient Information
4
4
Cardiac Arrest
3
3
Skin Tears
3
3
Complaint, Ill-Defined
2
2
Hypoventilation
2
2
No Code Available
2
2
No Patient Involvement
2
2
Cardiopulmonary Arrest
2
2
Physical Entrapment
2
2
Tachycardia
2
2
Hyperemia
2
2
Patient Problem/Medical Problem
1
1
Electric Shock
1
1
Failure of Implant
1
1
Necrosis
1
1
Bone Fracture(s)
1
1
Skin Disorders
1
1
Contusion
1
1
Skin Discoloration
1
1
Foreign Body In Patient
1
1
Loss Of Pulse
1
1
Dyspnea
1
1
Laceration(s)
1
1
Scar Tissue
1
1
Bradycardia
1
1
Unspecified Tissue Injury
1
1
Extubate
1
1
Unintended Extubation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arjo Hospital Equipment AB
II
Feb-27-2015
2
Arjohuntleigh Magog
II
Feb-05-2019
3
Kinsman Enterprises Inc
II
Oct-21-2021
4
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
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