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TPLC
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Device
bed, patient rotation, powered
Regulation Description
Powered patient rotation bed.
Product Code
IKZ
Regulation Number
890.5225
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
26
26
2017
35
35
2018
28
28
2019
27
27
2020
29
29
2021
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
53
53
Difficult to Open or Close
17
17
Insufficient Information
14
14
Use of Device Problem
9
9
Device Handling Problem
8
8
Break
6
6
Power Cord
5
5
Device Operates Differently Than Expected
5
5
Human Factors Issue
4
4
Mechanical Problem
4
4
Difficult To Position
3
3
No Display/Image
3
3
Electrical /Electronic Property Problem
3
3
Device Inoperable
3
3
Patient-Device Incompatibility
3
3
Defective Component
3
3
Device Issue
3
3
Cut In Material
3
3
Unintended Movement
3
3
Material Integrity Problem
2
2
Mechanical Jam
2
2
Material Too Soft/Flexible
2
2
No Apparent Adverse Event
2
2
Human-Device Interface Problem
2
2
Alarm, Audible
2
2
Device Alarm System
2
2
Low Audible Alarm
2
2
Loose or Intermittent Connection
2
2
Device Slipped
2
2
Deflation Problem
2
2
Difficult or Delayed Positioning
2
2
Product Quality Problem
2
2
Self-Activation or Keying
1
1
Improper or Incorrect Procedure or Method
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Device Difficult to Program or Calibrate
1
1
Device Emits Odor
1
1
Unintended System Motion
1
1
No Device Output
1
1
Wire
1
1
Plug
1
1
Ground Strap/Wire
1
1
Screen
1
1
Unintended Ejection
1
1
Fire
1
1
Thermal Decomposition of Device
1
1
Component Falling
1
1
Crack
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Dislodged or Dislocated
1
1
Operating System Becomes Nonfunctional
1
1
Positioning Problem
1
1
Scratched Material
1
1
Separation Failure
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Device Operational Issue
1
1
Unclear Information
1
1
Misassembly During Maintenance/Repair
1
1
Patient Device Interaction Problem
1
1
Appropriate Term/Code Not Available
1
1
Device Component Or Accessory
1
1
Device Subassembly
1
1
Electrical Wire
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pressure Sores
46
46
No Consequences Or Impact To Patient
26
26
No Known Impact Or Consequence To Patient
18
18
Injury
18
18
Tissue Damage
12
12
Pain
8
8
Low Oxygen Saturation
7
7
Death
6
6
Tissue Breakdown
5
5
No Clinical Signs, Symptoms or Conditions
3
3
Skin Tears
2
2
Fall
2
2
No Code Available
2
2
Patient Problem/Medical Problem
1
1
Loss Of Pulse
1
1
Bone Fracture(s)
1
1
Laceration(s)
1
1
Necrosis
1
1
Bradycardia
1
1
Cardiac Arrest
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Extubate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arjohuntleigh Magog
II
Feb-05-2019
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