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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
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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