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TPLC
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show TPLC since
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Device
bath, sitz, powered
Product Code
ILM
Regulation Number
890.5100
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
61
61
2015
14
14
2016
20
20
2017
6
6
2018
2
2
2019
6
6
2020
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Maintenance Does Not Comply To Manufacturers Recommendations
28
28
Device Tipped Over
19
19
Component Falling
15
15
Installation-Related Problem
13
13
Use of Device Problem
12
12
Adverse Event Without Identified Device or Use Problem
12
12
Detachment Of Device Component
11
11
Device Operational Issue
10
10
Leak/Splash
10
10
Unintended Movement
8
8
Device Maintenance Issue
6
6
Detachment of Device or Device Component
6
6
Temperature Problem
5
5
Chemical Spillage
5
5
Device Dislodged or Dislocated
5
5
Human Factors Issue
5
5
No Apparent Adverse Event
5
5
Shelf Life Exceeded
4
4
Unstable
4
4
Microbial Contamination of Device
3
3
Break
3
3
Biofilm coating in Device
3
3
Environmental Compatibility Problem
3
3
Smoking
2
2
Positioning Problem
2
2
Calibration Problem
2
2
Overheating of Device
2
2
Disconnection
1
1
Mechanical Jam
1
1
Failure to Disinfect
1
1
Unintended System Motion
1
1
Overfill
1
1
Failure To Adhere Or Bond
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Battery Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Operates Differently Than Expected
1
1
Device Inoperable
1
1
Component Incompatible
1
1
Filling Problem
1
1
Hole In Material
1
1
Device Fell
1
1
Crack
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
41
41
Fall
19
19
Injury
15
15
Pain
12
12
No Known Impact Or Consequence To Patient
9
9
Bruise/Contusion
8
8
No Patient Involvement
6
6
Urinary Tract Infection
5
5
Skin Tears
4
4
Superficial (First Degree) Burn
3
3
Head Injury
3
3
Bone Fracture(s)
3
3
Abrasion
3
3
Chemical Exposure
3
3
Irritation
3
3
Laceration(s)
3
3
Partial thickness (Second Degree) Burn
3
3
Tingling
2
2
Muscle Weakness
2
2
Burn(s)
2
2
Concussion
2
2
Eye Injury
2
2
Caustic/Chemical Burns
2
2
Tissue Damage
2
2
Sore Throat
2
2
Headache
2
2
Sweating
1
1
Death
1
1
Skin Irritation
1
1
Palpitations
1
1
Alteration In Body Temperature
1
1
Loss of consciousness
1
1
Ambulation Difficulties
1
1
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