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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
2021 11 11
2022 6 6
2023 20 20
2024 7 8
2025 12 14
2026 8 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Electrical /Electronic Property Problem 12 16
Material Too Soft/Flexible 9 9
Positioning Problem 7 7
Patient Device Interaction Problem 6 7
Insufficient Device Problem Information 3 3
Sharp Edges 3 4
Difficult or Delayed Positioning 2 2
No Apparent Adverse Event 2 2
Activation Problem 1 1
Patient-Device Incompatibility 1 1
Unintended Movement 1 1
Smoking 1 1
Electrical Overstress 1 1
Material Too Rigid or Stiff 1 2
Inflation Problem 1 1
Detachment of Device or Device Component 1 1
Electrical Shorting 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sore/Ulcer 28 28
No Clinical Signs, Symptoms or Conditions 23 28
Insufficient Information 5 5
Pain 2 2
Physical Entrapment 2 2
Hyperemia 2 2
Skin Disorders 1 2
Skin Discoloration 1 2
Rash 1 1
Discomfort 1 1
Fall 1 1
Scar Tissue 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Skin Tears 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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