TPLC - Total Product Life Cycle

• 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
2024	2	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
Material Integrity Problem	3	3
Detachment Of Device Component	3	3
Break	3	3
Device Slipped	2	2
Device Fell	2	6
Material Separation	2	3
Inadequacy of Device Shape and/or Size	2	2
Material Too Soft/Flexible	2	6
Device Tipped Over	2	2
Unstable	1	1
Crack	1	1
Material Disintegration	1	1
Positioning Problem	1	1
Scratched Material	1	1
Patient Device Interaction Problem	1	1
Use of Device Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Bent	1	1
Connection Problem	1	1
Loose or Intermittent Connection	1	1
Component Falling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	43	43
No Clinical Signs, Symptoms or Conditions	13	25
No Patient Involvement	12	17
No Code Available	10	10
No Information	2	2
Pain	2	2
Neuropathy	1	1
Injury	1	1
Nerve Damage	1	1
Fall	1	1
Laceration(s)	1	1
Physical Entrapment	1	1
No Consequences Or Impact To Patient	1	1
Deformity/ Disfigurement	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