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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 5 5

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 16 16
Device Operates Differently Than Expected 13 13
Microbial Contamination of Device 12 12
Failure To Adhere Or Bond 10 10
Detachment Of Device Component 9 9
Component Falling 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Unintended Movement 8 8
Unintended System Motion 8 8
Fracture 7 7
Mechanical Problem 7 7
Break 6 6
Detachment of Device or Device Component 6 6
Insufficient Information 6 6
Temperature Problem 4 4
Installation-Related Problem 4 4
Use of Device Problem 4 4
Material Separation 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Device Emits Odor 3 3
Unintended Electrical Shock 3 3
Sharp Edges 2 2
Torn Material 2 2
Chemical Spillage 2 2
Difficult to Open or Close 2 2
Smoking 2 2
Misassembled 2 2
Failure to Align 2 2
Thermal Decomposition of Device 2 2
Crack 2 2
Failure to Disinfect 2 2
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Filling Problem 1 1
Burst Container or Vessel 1 1
Bent 1 1
Migration or Expulsion of Device 1 1
Device Maintenance Issue 1 1
Difficult to Insert 1 1
Inability to Irrigate 1 1
Arcing 1 1
Patient-Device Incompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Safety interlock(s) inadequate 1 1
Component Missing 1 1
Device Issue 1 1
Moisture Damage 1 1
No Device Output 1 1
Overheating of Device 1 1
Device Inoperable 1 1
Unstable 1 1
Device Dislodged or Dislocated 1 1
Failure to Shut Off 1 1
Device Operational Issue 1 1
Connection Problem 1 1
Device Contamination With Biological Material 1 1
No Apparent Adverse Event 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Migration 1 1
Physical Resistance/Sticking 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 19 19
Fall 15 15
Pain 8 8
Bruise/Contusion 7 7
Burn(s) 5 5
Laceration(s) 5 5
Bone Fracture(s) 4 4
Injury 4 4
Skin Tears 4 4
Electric Shock 4 4
Chemical Exposure 3 3
Head Injury 3 3
Contusion 3 3
Skin Irritation 3 3
Insufficient Information 3 3
Caustic/Chemical Burns 2 2
Death 2 2
Erythema 2 2
Partial thickness (Second Degree) Burn 2 2
Decreased Respiratory Rate 2 2
Abrasion 1 1
Burn, Thermal 1 1
Skin Inflammation 1 1
Chest Tightness/Pressure 1 1
Eye Pain 1 1
Superficial (First Degree) Burn 1 1
Chest Pain 1 1
Headache 1 1
Swelling 1 1
Burning Sensation 1 1
Concussion 1 1
Myocardial Infarction 1 1
Respiratory Distress 1 1
Shock 1 1

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