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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
Adverse Event Without Identified Device or Use Problem 12 12
Use of Device Problem 12 12
Detachment Of Device Component 11 11
Leak/Splash 10 10
Device Operational Issue 10 10
Unintended Movement 8 8
Detachment of Device or Device Component 6 6
Device Maintenance Issue 6 6
Device Dislodged or Dislocated 5 5
No Apparent Adverse Event 5 5
Human Factors Issue 5 5
Temperature Problem 5 5
Chemical Spillage 5 5
Unstable 4 4
Shelf Life Exceeded 4 4
Environmental Compatibility Problem 3 3
Biofilm coating in Device 3 3
Microbial Contamination of Device 3 3
Break 3 3
Smoking 2 2
Overheating of Device 2 2
Positioning Problem 2 2
Calibration Problem 2 2
Device Inoperable 1 1
Component Incompatible 1 1
Mechanical Jam 1 1
Failure to Disinfect 1 1
Crack 1 1
Hole In Material 1 1
Unintended System Motion 1 1
Battery Problem 1 1
Fluid/Blood Leak 1 1
Failure To Adhere Or Bond 1 1
Use of Incorrect Control/Treatment Settings 1 1
Overfill 1 1
Device Fell 1 1
Filling Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Disconnection 1 1
Device Operates Differently Than Expected 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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