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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
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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