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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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42 42
Difficult to Open or Close 8 8
Electrical /Electronic Property Problem 7 7
Patient Device Interaction Problem 5 5
Use of Device Problem 4 4
Mechanical Problem 3 3
Material Too Soft/Flexible 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Sharp Edges 3 3
Mechanical Jam 2 2
Difficult or Delayed Positioning 2 2
Product Quality Problem 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Unintended Movement 2 2
Detachment of Device or Device Component 1 1
Defective Device 1 1
Self-Activation or Keying 1 1
Device Slipped 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
Device Alarm System 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
Intermittent Energy Output 1 1
Activation Problem 1 1
Unclear Information 1 1
Misassembly During Maintenance/Repair 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 42 42
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
Extubate 1 1
No Code Available 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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