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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bath, sitz, powered
Regulation Description Immersion hydrobath.
Product CodeILM
Regulation Number 890.5100
Device Class 2

Device Problems
Maintenance does not comply to manufacturers recommendations 32
Tipover 17
Component falling 16
Installation-related problem 14
Detachment of device component 12
Use of Device Issue 10
Bacterial contamination of device 9
Biofilm coating in device 9
No Known Device Problem 9
Unintended movement 7
Detachment of device or device component 7
Dislodged or dislocated 6
Unstable 6
Device maintenance issue 6
Break 5
Leak 5
Environmental control or utility issue 5
Temperature issue 4
Shelf life exceeded 4
Defective component 3
Component incompatible 3
Chemical spillage 3
Calibration issue 2
Defective item 2
Positioning Issue 2
Protective measure issue 2
Collapse 2
Component missing 2
Smoking 2
Overheating of device or device component 2
Material separation 2
Device inoperable 1
Overfill 1
Use of Incorrect Control Settings 1
Crack 1
Failure to disinfect 1
Filling problem 1
Mechanical jam 1
Battery issue 1
Total Device Problems 218

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