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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
2017
7
7
2018
56
56
2019
5
7
2020
7
12
2021
3
3
2022
3
7
2023
4
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
30
30
Device Operates Differently Than Expected
15
15
Sharp Edges
8
16
Material Deformation
7
7
Nonstandard Device
4
4
Break
3
3
Detachment Of Device Component
3
3
Material Integrity Problem
3
3
Device Tipped Over
2
2
Material Separation
2
3
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Device Fell
2
6
Bent
1
1
Unstable
1
1
Use of Device Problem
1
1
Component Falling
1
1
Crack
1
1
Material Disintegration
1
1
Connection Problem
1
1
Loose or Intermittent Connection
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Positioning Problem
1
1
Scratched Material
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
43
43
No Patient Involvement
12
17
No Clinical Signs, Symptoms or Conditions
11
19
No Code Available
10
10
No Information
2
2
Pain
2
2
No Consequences Or Impact To Patient
1
1
Physical Entrapment
1
1
Injury
1
1
Deformity/ Disfigurement
1
1
Fall
1
1
Laceration(s)
1
1
Nerve Damage
1
1
Neuropathy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Nemschoff Chairs, Inc.
I
Feb-01-2012
2
Stryker Medical Division of Stryker Corporation
II
Feb-07-2019
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