TPLC - Total Product Life Cycle

• Device: chair, with casters
• Regulation Description: Mechanical chair.
• Product Code: INM
• Regulation Number: 890.3100
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	9	9
2021	22	22
2022	11	13
2023	11	11
2024	8	8
2025	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Misassembly by Users	16	16
Use of Device Problem	7	7
Break	6	6
Insufficient Information	4	4
Unintended Movement	3	3
Device Fell	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Collapse	2	2
Misassembled During Installation	2	2
Device Slipped	1	1
Defective Component	1	1
Patient Device Interaction Problem	1	1
Sharp Edges	1	3
Misassembly During Maintenance/Repair	1	1
Detachment of Device or Device Component	1	1
Material Protrusion/Extrusion	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Unintended System Motion	1	1
Connection Problem	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	28	28
No Clinical Signs, Symptoms or Conditions	14	16
Head Injury	12	12
Bruise/Contusion	7	7
Insufficient Information	5	5
Laceration(s)	5	5
Bone Fracture(s)	4	4
Unspecified Infection	1	1
Joint Dislocation	1	1
Brain Injury	1	1
Abrasion	1	1
No Known Impact Or Consequence To Patient	1	1
Injury	1	1
Concussion	1	1
Pain	1	1
Eye Injury	1	1
Hydrocephalus	1	1
Unspecified Tissue Injury	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Accora Inc	II	Sep-13-2021
2	Ki Mobility Llc	III	Jan-07-2022
3	Sunrise Medical (US) LLC	II	Jul-28-2021