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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, manual
Regulation Description Manual adjustable hospital bed.
Product CodeFNJ
Regulation Number 880.5120
Device Class 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 8 8
2018 3 3
2019 7 7
2020 4 4
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Unintended Movement 4 4
Device Operates Differently Than Expected 3 3
Defective Component 2 2
Component Missing 2 2
Break 2 2
Device Slipped 2 2
Smoking 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Charred 1 1
Collapse 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Inadequacy of Device Shape and/or Size 1 1
Sparking 1 1
Installation-Related Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Defective Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Physical Entrapment 6 6
Fall 5 5
No Known Impact Or Consequence To Patient 5 5
Death 5 5
Laceration(s) 5 5
Injury 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Bone Fracture(s) 2 2
Hip Fracture 1 1
Loss of consciousness 1 1
Aortic Dissection 1 1
No Patient Involvement 1 1
No Information 1 1
Asphyxia 1 1
Pain 1 1
Paralysis 1 1
Spinal Column Injury 1 1
Suffocation 1 1
Eye Injury 1 1
Abrasion 1 1
Cardiac Arrest 1 1

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