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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
Product CodeILM
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2014 61 61
2015 14 14
2016 20 20
2017 6 6
2018 2 2
2019 6 6
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Maintenance Does Not Comply To Manufacturers Recommendations 28 28
Device Tipped Over 19 19
Component Falling 15 15
Installation-Related Problem 13 13
Use of Device Problem 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Detachment Of Device Component 11 11
Leak/Splash 10 10
Device Operational Issue 10 10
Unintended Movement 8 8
Device Maintenance Issue 6 6
Detachment of Device or Device Component 6 6
Chemical Spillage 5 5
Temperature Problem 5 5
No Apparent Adverse Event 5 5
Device Dislodged or Dislocated 5 5
Human Factors Issue 5 5
Unstable 4 4
Shelf Life Exceeded 4 4
Microbial Contamination of Device 3 3
Environmental Compatibility Problem 3 3
Biofilm coating in Device 3 3
Break 3 3
Calibration Problem 2 2
Positioning Problem 2 2
Smoking 2 2
Overheating of Device 2 2
Hole In Material 1 1
Fluid/Blood Leak 1 1
Unintended System Motion 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure To Adhere Or Bond 1 1
Battery Problem 1 1
Device Inoperable 1 1
Component Incompatible 1 1
Device Operates Differently Than Expected 1 1
Filling Problem 1 1
Device Fell 1 1
Crack 1 1
Failure to Disinfect 1 1
Mechanical Jam 1 1
Use of Incorrect Control/Treatment Settings 1 1
Overfill 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 41 41
Fall 19 19
Injury 15 15
Pain 12 12
No Known Impact Or Consequence To Patient 9 9
Bruise/Contusion 8 8
No Patient Involvement 6 6
Urinary Tract Infection 5 5
Skin Tears 4 4
Superficial (First Degree) Burn 3 3
Bone Fracture(s) 3 3
Head Injury 3 3
Abrasion 3 3
Chemical Exposure 3 3
Irritation 3 3
Laceration(s) 3 3
Partial thickness (Second Degree) Burn 3 3
Tingling 2 2
Muscle Weakness 2 2
Burn(s) 2 2
Concussion 2 2
Eye Injury 2 2
Tissue Damage 2 2
Caustic/Chemical Burns 2 2
Headache 2 2
Sore Throat 2 2
Death 1 1
Sweating 1 1
Skin Irritation 1 1
Palpitations 1 1
Alteration In Body Temperature 1 1
Loss of consciousness 1 1
Ambulation Difficulties 1 1

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