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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
2016 17 17
2017 8 8
2018 11 11
2019 13 13
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Detachment of Device or Device Component 8 8
Use of Device Problem 5 5
Unintended Movement 5 5
Device Operates Differently Than Expected 4 4
Device Tipped Over 3 3
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Collapse 2 2
Caster 2 2
Disconnection 2 2
Fracture 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Device Fell 2 2
Unintended System Motion 1 1
Device Slipped 1 1
Device Inoperable 1 1
Unstable 1 1
Material Fragmentation 1 1
Lock 1 1
Loss of or Failure to Bond 1 1
Detachment Of Device Component 1 1
Crack 1 1
Screw 1 1
Belt 1 1
Bolt 1 1
Brake 1 1
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Expulsion 1 1
Human Factors Issue 1 1
Material Protrusion/Extrusion 1 1
Device Subassembly 1 1
Locking Mechanism 1 1
Wheel 1 1
Wheelchair, Wheels 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 21 21
Bone Fracture(s) 13 13
Laceration(s) 8 8
Injury 8 8
Head Injury 4 4
Bruise/Contusion 4 4
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Cellulitis 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
No Information 2 2
No Code Available 1 1
Tooth Fracture 1 1
Vomiting 1 1
Weakness 1 1
Brain Injury 1 1
Death 1 1
Hip Fracture 1 1
Neck Pain 1 1
Abrasion 1 1
Sprain 1 1
Swelling 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 R82 A/S II May-11-2019
2 R82 A/S II Nov-09-2018
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