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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

Device Problems
Adverse Event Without Identified Device or Use Problem 30
Difficult to Open or Close 17
Use of Device Problem 13
Device Handling Problem 9
Device Inoperable 7
Defective Component 6
Insufficient Information 5
Human Factors Issue 4
Detachment Of Device Component 4
Unintended Movement 4
Device Issue 3
Break 3
Mechanical Problem 3
Cut In Material 3
Unintended System Motion 3
Electrical /Electronic Property Problem 2
No Display / Image 2
Human-Device Interface Problem 2
Low Audible Alarm 2
Difficult To Position 2
Material Too Soft / Flexible 1
No Device Output 1
Crack 1
Device Alarm System 1
Component Falling 1
Separation Failure 1
Mechanical Jam 1
Unclear Information 1
Inflation Problem 1
Patient-Device Incompatibility 1
Device Operational Issue 1
Misconnection 1
Device Stops Intermittently 1
Smoking 1
Deflation Problem 1
Device Dislodged or Dislocated 1
No Apparent Adverse Event 1
Device Displays Incorrect Message 1
Total Device Problems 142

Recalls
Manufacturer Recall Class Date Posted
1 Arjo Hospital Equipment AB II Feb-27-2015
2 Arjohuntleigh Magog II Feb-05-2019

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