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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
2019 7 7
2020 4 4
2021 8 8
2022 23 23
2023 60 60
2024 44 44
2025 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 86 86
No Audible Alarm 26 26
Material Split, Cut or Torn 24 24
Activation Problem 14 14
Adverse Event Without Identified Device or Use Problem 7 7
Material Frayed 6 6
Collapse 6 6
Mechanical Problem 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 3 3
Defective Alarm 3 3
Insufficient Information 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Break 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Device Alarm System 1 1
Device Damaged Prior to Use 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Sharp Edges 1 1
Material Deformation 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 1 1
Installation-Related Problem 1 1
No Apparent Adverse Event 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 165 165
Fall 11 11
Laceration(s) 5 5
Insufficient Information 4 4
Bruise/Contusion 4 4
Physical Entrapment 3 3
Bone Fracture(s) 2 2
Strangulation 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hip Fracture 1 1
Head Injury 1 1
Hematoma 1 1
Crushing Injury 1 1
Injury 1 1
No Patient Involvement 1 1
Pain 1 1
Eye Injury 1 1
Limb Fracture 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Oakworks Inc II Jun-06-2022
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