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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
Product CodeIKZ
Regulation Number 890.5225
Device Class 2

MDR Year MDR Reports MDR Events
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 43 43
Difficult to Open or Close 8 8
Electrical /Electronic Property Problem 7 7
Patient Device Interaction Problem 6 6
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Insufficient Information 3 3
Sharp Edges 3 3
Mechanical Problem 3 3
Material Too Soft/Flexible 3 3
Unintended Movement 2 2
Difficult or Delayed Positioning 2 2
Defective Component 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Pressure Problem 1 1
Device Alarm System 1 1
Intermittent Energy Output 1 1
Activation Problem 1 1
Unclear Information 1 1
Misassembly During Maintenance/Repair 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
No Display/Image 1 1
Fire 1 1
Inflation Problem 1 1
Unintended System Motion 1 1
Failure to Power Up 1 1
Device Difficult to Program or Calibrate 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 43 43
No Consequences Or Impact To Patient 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Injury 5 5
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
Low Oxygen Saturation 2 2
Tissue Breakdown 2 2
Physical Entrapment 2 2
Tissue Damage 2 2
Pain 2 2
Hyperemia 2 2
Laceration(s) 1 1
Necrosis 1 1
Cardiopulmonary Arrest 1 1
Fall 1 1
Bone Fracture(s) 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Extubate 1 1
No Code Available 1 1
Skin Disorders 1 1
Unspecified Tissue Injury 1 1
Unintended Extubation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arjohuntleigh Magog II Feb-05-2019
2 Kinsman Enterprises Inc II Oct-21-2021
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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