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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
2018 56 56
2019 5 7
2020 7 12
2021 3 3
2022 3 7

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 30 30
Device Operates Differently Than Expected 15 15
Material Deformation 7 7
Sharp Edges 7 15
Nonstandard Device 4 4
Device Slipped 2 2
Material Integrity Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Unstable 1 1
Device Fell 1 4
Patient Device Interaction Problem 1 1
Material Separation 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 40 40
No Patient Involvement 11 16
No Code Available 10 10
No Clinical Signs, Symptoms or Conditions 7 13
No Information 2 2
Fall 1 1
Physical Entrapment 1 1
Neuropathy 1 1
Deformity/ Disfigurement 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Injury 1 1

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