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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
Adverse Event Without Identified Device or Use Problem 9 9
Component Falling 9 9
Detachment Of Device Component 9 9
Unintended Movement 8 8
Unintended System Motion 8 8
Fracture 7 7
Mechanical Problem 7 7
Detachment of Device or Device Component 6 6
Break 6 6
Insufficient Information 6 6
Temperature Problem 4 4
Installation-Related Problem 4 4
Use of Device Problem 4 4
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Unintended Electrical Shock 3 3
Device Emits Odor 3 3
Material Separation 3 3
Failure to Disinfect 2 2
Chemical Spillage 2 2
Crack 2 2
Torn Material 2 2
Failure to Align 2 2
Thermal Decomposition of Device 2 2
Sharp Edges 2 2
Smoking 2 2
Difficult to Open or Close 2 2
Misassembled 2 2
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Component Missing 1 1
Bent 1 1
Patient-Device Incompatibility 1 1
Burst Container or Vessel 1 1
Migration or Expulsion of Device 1 1
Material Twisted/Bent 1 1
Device Operational Issue 1 1
Migration 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Device Inoperable 1 1
Safety interlock(s) inadequate 1 1
Moisture or Humidity Problem 1 1
Inability to Irrigate 1 1
Mechanics Altered 1 1
Difficult to Insert 1 1
Moisture Damage 1 1
Overheating of Device 1 1
Filling Problem 1 1
Failure to Shut Off 1 1
No Device Output 1 1
Display or Visual Feedback Problem 1 1
Arcing 1 1
Physical Resistance/Sticking 1 1
Device Contamination With Biological Material 1 1
Device Maintenance Issue 1 1
Device Issue 1 1
Mechanical Jam 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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