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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
2018 28 28
2019 27 27
2020 29 29
2021 11 11
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Difficult to Open or Close 13 13
Insufficient Information 11 11
Electrical /Electronic Property Problem 5 5
Use of Device Problem 4 4
Material Too Soft/Flexible 3 3
No Apparent Adverse Event 3 3
Mechanical Problem 3 3
Patient-Device Incompatibility 3 3
Mechanical Jam 2 2
Patient Device Interaction Problem 2 2
Product Quality Problem 2 2
Defective Component 2 2
Unintended Movement 2 2
Sharp Edges 2 2
Difficult or Delayed Positioning 2 2
Misassembly During Maintenance/Repair 1 1
Device Alarm System 1 1
Component Falling 1 1
Device Difficult to Program or Calibrate 1 1
Self-Activation or Keying 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Device Output 1 1
Difficult To Position 1 1
Device Slipped 1 1
Break 1 1
Crack 1 1
No Display/Image 1 1
Unintended Ejection 1 1
Intermittent Energy Output 1 1
Defective Device 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Pressure Problem 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Unclear Information 1 1
Operating System Becomes Nonfunctional 1 1
Fire 1 1
Failure to Power Up 1 1
Device Issue 1 1
Device Operates Differently Than Expected 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 40 40
No Consequences Or Impact To Patient 18 18
Injury 11 11
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 7 7
Tissue Breakdown 4 4
Tissue Damage 4 4
Pain 3 3
Death 2 2
Physical Entrapment 2 2
Low Oxygen Saturation 2 2
Fall 1 1
Extubate 1 1
Bone Fracture(s) 1 1
Necrosis 1 1
No Code Available 1 1
Scar Tissue 1 1
Laceration(s) 1 1
Unintended Extubation 1 1
Insufficient Information 1 1
Cardiopulmonary Arrest 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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