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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
2014
80
80
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
79
79
Insufficient Information
28
28
Break
27
27
Moisture Damage
21
21
Difficult to Open or Close
17
17
Use of Device Problem
17
17
Device Operates Differently Than Expected
15
15
Electrical /Electronic Property Problem
11
11
Device Inoperable
9
9
Device Handling Problem
9
9
Defective Component
8
8
Device Displays Incorrect Message
8
8
Contamination
8
8
Mechanical Problem
7
7
Fluid/Blood Leak
7
7
Unintended System Motion
6
6
Material Discolored
6
6
Improper or Incorrect Procedure or Method
6
6
Sticking
5
5
Patient Device Interaction Problem
5
5
Unintended Movement
5
5
Torn Material
4
4
Device Slipped
4
4
No Display/Image
4
4
Patient-Device Incompatibility
4
4
Cut In Material
4
4
Human Factors Issue
4
4
Positioning Problem
4
4
Deflation Problem
4
4
Detachment Of Device Component
4
4
Bent
3
3
Difficult To Position
3
3
Material Integrity Problem
3
3
Device Issue
3
3
Detachment of Device or Device Component
3
3
Sharp Edges
3
3
No Apparent Adverse Event
3
3
Material Too Soft/Flexible
3
3
Sparking
2
2
Human-Device Interface Problem
2
2
Device Operational Issue
2
2
Device Dislodged or Dislocated
2
2
Defective Device
2
2
Scratched Material
2
2
Mechanical Jam
2
2
Material Puncture/Hole
2
2
Product Quality Problem
2
2
Hole In Material
2
2
Inflation Problem
2
2
Loose or Intermittent Connection
2
2
Misconnection
2
2
Low Audible Alarm
2
2
Device Alarm System
2
2
Difficult or Delayed Positioning
2
2
Crack
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Disconnection
1
1
Unintended Ejection
1
1
Fire
1
1
False Alarm
1
1
Component Falling
1
1
Thermal Decomposition of Device
1
1
Device Emits Odor
1
1
Self-Activation or Keying
1
1
No Device Output
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Device Difficult to Program or Calibrate
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Operating System Becomes Nonfunctional
1
1
Output Problem
1
1
Pressure Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Separation Failure
1
1
Smoking
1
1
Device Stops Intermittently
1
1
Inadequate or Insufficient Training
1
1
Physical Resistance/Sticking
1
1
Noise, Audible
1
1
Appropriate Term/Code Not Available
1
1
Intermittent Energy Output
1
1
Activation Problem
1
1
Unclear Information
1
1
Misassembly During Maintenance/Repair
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
79
79
Pressure Sores
68
68
No Consequences Or Impact To Patient
44
44
Injury
20
20
Death
17
17
Tissue Damage
12
12
No Clinical Signs, Symptoms or Conditions
12
12
Fall
11
11
Tissue Breakdown
10
10
Low Oxygen Saturation
9
9
Pain
9
9
No Information
8
8
Insufficient Information
4
4
Skin Tears
3
3
Skin Erosion
3
3
Cardiac Arrest
3
3
Cardiopulmonary Arrest
2
2
Tachycardia
2
2
Hyperemia
2
2
Hypoventilation
2
2
Physical Entrapment
2
2
Complaint, Ill-Defined
2
2
No Code Available
2
2
Loss Of Pulse
2
2
No Patient Involvement
2
2
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Unspecified Tissue Injury
1
1
Unintended Extubation
1
1
Loss of Vision
1
1
Electric Shock
1
1
Extubate
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Necrosis
1
1
Scar Tissue
1
1
Contusion
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Bone Fracture(s)
1
1
Dyspnea
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arjo Hospital Equipment AB
II
Feb-27-2015
2
ArjoHuntleigh Inc.
II
Feb-04-2014
3
Arjohuntleigh Magog
II
Feb-05-2019
4
KCI USA, Inc.
II
May-10-2011
5
KCI USA, Inc.
II
Dec-13-2010
6
Kinsman Enterprises Inc
II
Oct-21-2021
7
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
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