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TPLC
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show TPLC since
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2024
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Device
bed, manual
Product Code
FNJ
Regulation Number
880.5120
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
7
7
2020
4
4
2021
8
8
2022
23
23
2023
60
60
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
39
39
No Audible Alarm
19
19
Material Split, Cut or Torn
11
11
Activation Problem
8
8
Appropriate Term/Code Not Available
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Collapse
4
4
Mechanical Problem
4
4
Material Frayed
3
3
Defective Alarm
2
2
Defective Component
2
2
Patient Device Interaction Problem
2
2
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Component Missing
1
1
Activation, Positioning or Separation Problem
1
1
Installation-Related Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Device Damaged Prior to Use
1
1
Device Alarm System
1
1
Break
1
1
Loose or Intermittent Connection
1
1
Electrical /Electronic Property Problem
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89
89
Fall
9
9
Laceration(s)
5
5
Physical Entrapment
3
3
Bone Fracture(s)
2
2
Bruise/Contusion
2
2
Eye Injury
1
1
Hematoma
1
1
Injury
1
1
Hip Fracture
1
1
Loss of consciousness
1
1
No Patient Involvement
1
1
Limb Fracture
1
1
Insufficient Information
1
1
Pain
1
1
Strangulation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Oakworks Inc
II
Jun-06-2022
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