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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lift, patient, ac-powered
Regulation Description AC-powered patient lift.
Product CodeFNG
Regulation Number 880.5500
Device Class 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 4 4
2022 5 5
2023 16 16
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Device Tipped Over 2 2
Inaccurate Synchronization 1 1
Sharp Edges 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Fumes or Vapors 1 1
Material Erosion 1 1
Device Fell 1 1
Device Slipped 1 1
Separation Failure 1 1
Unintended System Motion 1 1
Physical Resistance/Sticking 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Collapse 1 1
Defective Device 1 1
Overheating of Device 1 1
Failure to Auto Stop 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Fall 6 6
Laceration(s) 4 4
Bone Fracture(s) 4 4
Hip Fracture 1 1
Bruise/Contusion 1 1
Injury 1 1
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Raye's Inc. II Apr-18-2024
2 Tollos II Nov-17-2022
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