TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2014	677	677
2015	15	15
2016	18	18
2017	8	8
2018	11	11
2019	13	13
2020	9	9
2021	22	22
2022	11	13
2023	11	11
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	230	230
Product Quality Problem	76	76
Unstable	75	75
Detachment Of Device Component	62	62
Torn Material	57	57
Bent	51	51
Device Operates Differently Than Expected	28	28
Crack	22	22
Adverse Event Without Identified Device or Use Problem	17	17
Use of Device Problem	16	16
Material Frayed	16	16
Unintended Movement	16	16
Misassembly by Users	16	16
Device Inoperable	14	14
Split	12	12
Detachment of Device or Device Component	11	11
Device Tipped Over	8	8
Unraveled Material	8	8
Material Separation	8	8
Device Slipped	8	8
Improper or Incorrect Procedure or Method	7	7
Naturally Worn	7	7
Material Integrity Problem	6	6
Defective Component	6	6
Out-Of-Box Failure	6	6
Insufficient Information	5	5
Device Fell	5	5
Loose or Intermittent Connection	5	5
Mechanical Problem	5	5
Difficult to Fold, Unfold or Collapse	4	4
Collapse	4	4
Component Falling	3	3
Material Disintegration	3	3
Unintended System Motion	3	3
Hole In Material	3	3
Mechanical Jam	3	3
Material Protrusion/Extrusion	2	2
Device Dislodged or Dislocated	2	2
Misassembled During Installation	2	2
Noise, Audible	2	2
Air Leak	2	2
Inflation Problem	2	2
Leak/Splash	2	2
Sticking	2	2
Fracture	2	2
Disconnection	2	2
Material Fragmentation	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Flaked	1	1
Component(s), broken	1	1
Loss of or Failure to Bond	1	1
Channeling	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Function indicator light(s), failure of	1	1
Overheating of Device	1	1
Unintended Collision	1	1
Device-Device Incompatibility	1	1
Deformation Due to Compressive Stress	1	1
Component or Accessory Incompatibility	1	1
Connection Problem	1	1
Cut In Material	1	1
Failure to Align	1	1
Defective Device	1	1
Component Missing	1	1
Patient Device Interaction Problem	1	1
Sharp Edges	1	3
Misassembly During Maintenance/Repair	1	1
Appropriate Term/Code Not Available	1	1
Electrical Shorting	1	1
Expulsion	1	1
Human Factors Issue	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	589	589
Fall	74	74
No Known Impact Or Consequence To Patient	52	52
Injury	20	20
Head Injury	17	17
Bone Fracture(s)	16	16
Bruise/Contusion	13	13
No Clinical Signs, Symptoms or Conditions	13	15
No Information	11	11
Laceration(s)	11	11
Pain	5	5
Concussion	5	5
Death	4	4
Skin Tears	4	4
Insufficient Information	4	4
Hip Fracture	2	2
Fracture, Arm	2	2
Brain Injury	2	2
Hemorrhage/Bleeding	2	2
Unspecified Infection	2	2
Swelling	2	2
Cellulitis	2	2
Abrasion	2	2
Erosion	1	1
Headache	1	1
Visual Impairment	1	1
Vomiting	1	1
Weakness	1	1
Undesired Nerve Stimulation	1	1
Discomfort	1	1
Complaint, Ill-Defined	1	1
Unknown (for use when the patient's condition is not known)	1	1
Sprain	1	1
Tooth Fracture	1	1
Neck Pain	1	1
Suture Abrasion	1	1
Ambulation Difficulties	1	1
No Patient Involvement	1	1
Not Applicable	1	1
No Code Available	1	1
Hydrocephalus	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Accora Inc	II	Sep-13-2021
2	Ki Mobility Llc	III	Jan-07-2022
3	Nemschoff Chairs, Inc.	II	Oct-06-2014
4	R82 A/S	II	May-11-2019
5	R82 A/S	II	Nov-09-2018
6	Sunrise Medical (US) LLC	II	Jul-28-2021
7	Winco Mfg., LLC	II	Feb-26-2014
8	Winco Mfg., LLC	II	Feb-04-2013
9	Winco Mfg., LLC	II	Oct-10-2012
10	Winco Mfg., LLC	II	Apr-25-2012
11	Winco Mfg., LLC	II	Feb-26-2012
12	Winco, Inc.	II	Oct-27-2010