TPLC - Total Product Life Cycle

• Device: chair and table, medical
• Product Code: KMN
• Regulation Number: 880.6140
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	8	8
2015	22	22
2016	11	11
2017	2	2
2018	7	7
2019	2	2
2020	3	3
2022	2	2
2023	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	19	19
Bent	9	9
Device Slipped	7	7
Insufficient Information	7	7
Device Operates Differently Than Expected	4	4
Collapse	4	4
Unstable	3	3
Improper or Incorrect Procedure or Method	2	2
Mechanical Problem	2	2
Material Deformation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	1	1
Sharp Edges	1	1
Mechanics Altered	1	1
Naturally Worn	1	1
Device Inoperable	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Component Missing	1	1
Split	1	1
Device Tipped Over	1	1
Malposition of Device	1	1
Detachment of Device or Device Component	1	1
Device Misassembled During Manufacturing /Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	19	19
No Known Impact Or Consequence To Patient	19	19
Insufficient Information	11	11
No Patient Involvement	4	4
Fall	4	4
Hip Fracture	2	2
Abrasion	2	2
No Information	2	2
Swelling/ Edema	1	1
Wound Dehiscence	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bruise/Contusion	1	1
Neck Pain	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Invacare Corporation	II	Sep-26-2012
2	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021