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TPLC
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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 Code
NZG
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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