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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, patient rotation, powered
Regulation Description Powered patient rotation bed.
Product CodeIKZ
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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