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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bassinet, hospital
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
2019 5 7
2020 7 12
2021 3 3
2022 3 7
2023 4 6
2024 2 6

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 8 16
Material Integrity Problem 3 3
Material Separation 2 3
Inadequacy of Device Shape and/or Size 2 2
Device Fell 2 6
Material Too Soft/Flexible 2 6
Adverse Event Without Identified Device or Use Problem 1 1
Unstable 1 1
Device Slipped 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 25
No Patient Involvement 8 13
Neuropathy 1 1
Injury 1 1
Nerve Damage 1 1
Fall 1 1
Laceration(s) 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Feb-07-2019
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