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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, hydro-massage
Product CodeILJ
Regulation Number 890.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ARJO HOSPITAL EQUIPMENT AB
  SUBSTANTIALLY EQUIVALENT 1
ARJOHUNTLEIGH INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 188 188
2015 72 72
2016 57 57
2017 26 26
2018 21 21
2019 22 22
2020 14 14
2021 6 6
2022 12 12
2023 13 13
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 237 237
Device Fell 24 24
Fluid/Blood Leak 21 21
Device Tipped Over 17 17
Device Operates Differently Than Expected 13 13
Microbial Contamination of Device 12 12
Failure To Adhere Or Bond 10 10
Component Falling 9 9
Detachment Of Device Component 9 9
Unintended System Motion 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Unintended Movement 8 8
Mechanical Problem 7 7
Detachment of Device or Device Component 7 7
Fracture 7 7
Break 6 6
Insufficient Information 6 6
No Apparent Adverse Event 4 4
Installation-Related Problem 4 4
Temperature Problem 4 4
Use of Device Problem 4 4
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Device Emits Odor 3 3
Material Separation 3 3
Unintended Electrical Shock 3 3
Misassembled 2 2
Chemical Spillage 2 2
Difficult to Open or Close 2 2
Failure to Disinfect 2 2
Sharp Edges 2 2
Thermal Decomposition of Device 2 2
Failure to Align 2 2
Smoking 2 2
Crack 2 2
Torn Material 2 2
Display or Visual Feedback Problem 1 1
Arcing 1 1
Electrical /Electronic Property Problem 1 1
Device Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Migration or Expulsion of Device 1 1
Burst Container or Vessel 1 1
Physical Resistance/Sticking 1 1
Migration 1 1
Inability to Irrigate 1 1
Patient-Device Incompatibility 1 1
Filling Problem 1 1
Device Operational Issue 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 221 221
No Information 81 81
No Patient Involvement 35 35
No Consequences Or Impact To Patient 31 31
No Clinical Signs, Symptoms or Conditions 22 22
Fall 15 15
Pain 8 8
Bruise/Contusion 7 7
Burn(s) 5 5
Laceration(s) 5 5
Electric Shock 4 4
Bone Fracture(s) 4 4
Injury 4 4
Skin Tears 4 4
Skin Irritation 3 3
Head Injury 3 3
Chemical Exposure 3 3
Contusion 3 3
Insufficient Information 3 3
Death 2 2
Erythema 2 2
Caustic/Chemical Burns 2 2
Partial thickness (Second Degree) Burn 2 2
Decreased Respiratory Rate 2 2
Superficial (First Degree) Burn 1 1
Respiratory Distress 1 1
Abrasion 1 1
Chest Tightness/Pressure 1 1
Burn, Thermal 1 1
Burning Sensation 1 1
Chest Pain 1 1
Swelling 1 1
Concussion 1 1
Skin Inflammation 1 1
Shock 1 1
Myocardial Infarction 1 1
Headache 1 1
Eye Pain 1 1

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