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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
Installation-related problem 14
Component falling 14
Tipover 13
Use of Device Issue 10
Detachment of device component 10
Bacterial contamination of device 9
Biofilm coating in device 9
No Known Device Problem 9
Detachment of device or device component 7
Device maintenance issue 6
Unintended movement 6
Leak 5
Environmental control or utility issue 5
Dislodged or dislocated 5
Unstable 5
Temperature issue 4
Break 4
Shelf life exceeded 4
Component incompatible 3
Chemical spillage 3
Defective component 3
Component missing 2
Smoking 2
Material separation 2
Protective measure issue 2
Overheating of device or device component 2
Collapse 2
Defective item 2
Calibration issue 2
Positioning Issue 2
Crack 1
Mechanical jam 1
Use of Incorrect Control Settings 1
Overfill 1
Battery issue 1
Device inoperable 1
Total Device Problems 204

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