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

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