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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
Mechanical Problem 3 3
Insufficient Information 3 3
Sharp Edges 3 3
Material Too Soft/Flexible 3 3
Patient-Device Incompatibility 2 2
Unintended Movement 2 2
Defective Component 2 2
Difficult or Delayed Positioning 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Device Slipped 1 1
Operating System Becomes Nonfunctional 1 1
Pressure Problem 1 1
No Display/Image 1 1
Fire 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Device Alarm System 1 1
Intermittent Energy Output 1 1
Unclear Information 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Power Up 1 1
Material Too Rigid or Stiff 1 1
Misassembly During Maintenance/Repair 1 1
Inflation Problem 1 1
Device Difficult to Program or Calibrate 1 1
Detachment of Device or Device Component 1 1
Unintended System Motion 1 1
Human-Device Interface Problem 1 1
Self-Activation or Keying 1 1
Improper or Incorrect Procedure or Method 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
No Known Impact Or Consequence To Patient 5 5
Injury 5 5
Insufficient Information 4 4
Pain 2 2
Physical Entrapment 2 2
Tissue Damage 2 2
Low Oxygen Saturation 2 2
Tissue Breakdown 2 2
Hyperemia 2 2
No Code Available 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Skin Disorders 1 1
Skin Discoloration 1 1
Cardiopulmonary Arrest 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Fall 1 1
Unspecified Tissue Injury 1 1
Extubate 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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