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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chair, with casters
Regulation Description Mechanical chair.
Product CodeINM
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
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