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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bassinet, hospital
Regulation Description Medical bassinet.
Definition Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.
Product CodeNZG
Regulation Number 880.5145
Device Class 2

MDR Year MDR Reports MDR Events
2020 7 12
2021 3 3
2022 3 7
2023 4 6
2024 3 7
2025 1 9

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 6 12
Device Fell 3 15
Material Integrity Problem 3 3
Material Too Soft/Flexible 3 7
Material Separation 2 3
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 35
No Patient Involvement 5 8
Fall 1 1
Deformity/ Disfigurement 1 1

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