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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, manual
Product CodeFNJ
Regulation Number 880.5120
Device Class 1

MDR Year MDR Reports MDR Events
2014 20 20
2015 9 9
2016 3 3
2017 8 8
2018 3 3
2019 7 7
2020 4 4
2021 8 8
2022 23 23
2023 60 60
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 45 45
No Audible Alarm 19 19
Material Split, Cut or Torn 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Break 10 10
Activation Problem 9 9
Mechanical Problem 6 6
Device Operates Differently Than Expected 5 5
Appropriate Term/Code Not Available 5 5
Collapse 4 4
Bent 3 3
Component Missing 3 3
Material Frayed 3 3
Device Slipped 3 3
Use of Device Problem 2 2
Loose or Intermittent Connection 2 2
Defective Component 2 2
Installation-Related Problem 2 2
Defective Alarm 2 2
Detachment Of Device Component 2 2
Electrical /Electronic Property Problem 2 2
Entrapment of Device 2 2
Patient Device Interaction Problem 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Fracture 1 1
Charred 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Component Falling 1 1
Crack 1 1
Material Disintegration 1 1
Device Alarm System 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Defective Device 1 1
Sparking 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Smoking 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 93
No Known Impact Or Consequence To Patient 24 24
Fall 12 12
Laceration(s) 6 6
Physical Entrapment 6 6
Death 5 5
Injury 4 4
No Information 3 3
Bruise/Contusion 3 3
Bone Fracture(s) 3 3
No Consequences Or Impact To Patient 2 2
Pain 2 2
Hip Fracture 2 2
Insufficient Information 2 2
Arthralgia 1 1
Loss of consciousness 1 1
Aortic Dissection 1 1
No Patient Involvement 1 1
No Code Available 1 1
Limb Fracture 1 1
Paralysis 1 1
Spinal Column Injury 1 1
Strangulation 1 1
Suffocation 1 1
Abrasion 1 1
Discomfort 1 1
Head Injury 1 1
Hematoma 1 1
Asphyxia 1 1
Cardiac Arrest 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom, Inc. II Aug-03-2010
2 Oakworks Inc II Jun-06-2022
3 Stryker Medical Div. of Stryker Corporation II Sep-01-2010
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