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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
Detachment of Device or Device Component 6 6
Device Maintenance Issue 6 6
Chemical Spillage 5 5
Device Dislodged or Dislocated 5 5
Human Factors Issue 5 5
No Apparent Adverse Event 5 5
Temperature Problem 5 5
Unstable 4 4
Shelf Life Exceeded 4 4
Biofilm coating in Device 3 3
Break 3 3
Microbial Contamination of Device 3 3
Environmental Compatibility Problem 3 3
Calibration Problem 2 2
Overheating of Device 2 2
Smoking 2 2
Positioning Problem 2 2
Mechanical Jam 1 1
Device Fell 1 1
Device Inoperable 1 1
Overfill 1 1
Battery Problem 1 1
Device Operates Differently Than Expected 1 1
Failure To Adhere Or Bond 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unintended System Motion 1 1
Component Incompatible 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Disconnection 1 1
Failure to Disinfect 1 1
Filling Problem 1 1
Fluid/Blood Leak 1 1
Hole In Material 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
Partial thickness (Second Degree) Burn 3 3
Chemical Exposure 3 3
Superficial (First Degree) Burn 3 3
Abrasion 3 3
Bone Fracture(s) 3 3
Head Injury 3 3
Irritation 3 3
Laceration(s) 3 3
Muscle Weakness 2 2
Sore Throat 2 2
Headache 2 2
Eye Injury 2 2
Burn(s) 2 2
Tingling 2 2
Concussion 2 2
Tissue Damage 2 2
Caustic/Chemical Burns 2 2
Alteration In Body Temperature 1 1
Ambulation Difficulties 1 1
Death 1 1
Loss of consciousness 1 1
Sweating 1 1
Palpitations 1 1
Skin Irritation 1 1

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