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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
2020 29 29
2021 11 11
2022 6 6
2023 20 20
2024 7 7
2025 3 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35 35
Electrical /Electronic Property Problem 9 11
Patient Device Interaction Problem 6 6
No Apparent Adverse Event 4 4
Insufficient Information 3 3
Use of Device Problem 3 3
Sharp Edges 3 3
Material Too Soft/Flexible 3 3
Defective Component 2 2
Difficult or Delayed Positioning 2 2
Device Slipped 1 1
Operating System Becomes Nonfunctional 1 1
Pressure Problem 1 1
No Display/Image 1 1
Mechanical Problem 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Intermittent Energy Output 1 1
Patient-Device Incompatibility 1 1
Defective Device 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
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 34 34
No Clinical Signs, Symptoms or Conditions 17 19
Insufficient Information 5 5
Injury 3 3
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Physical Entrapment 2 2
No Consequences Or Impact To Patient 2 2
Hyperemia 2 2
Tissue Breakdown 2 2
No Code Available 1 1
Bone Fracture(s) 1 1
Skin Disorders 1 1
Skin Discoloration 1 1
Fall 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Unspecified Tissue Injury 1 1
Extubate 1 1
Low Oxygen Saturation 1 1
Unintended Extubation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kinsman Enterprises Inc II Oct-21-2021
2 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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