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TPLC
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show TPLC since
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2024
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Device
bath, hydro-massage
Product Code
ILJ
Regulation Number
890.5100
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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