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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, positioning, electric
Regulation Description Electric positioning chair.
Product CodeINO
Regulation Number 890.3110
Device Class 2

MDR Year MDR Reports MDR Events
2020 41 44
2021 49 49
2022 29 33
2023 29 29
2024 20 26
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 135 135
Electrical /Electronic Property Problem 16 23
No Apparent Adverse Event 7 7
No Audible Alarm 5 9
Use of Device Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Unintended System Motion 5 5
Mechanical Problem 4 6
Material Too Rigid or Stiff 4 4
Fire 3 3
Device Fell 3 3
Improper or Incorrect Procedure or Method 2 2
Sparking 1 1
Break 1 1
Device Alarm System 1 1
Patient-Device Incompatibility 1 1
Smoking 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Sharp Edges 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Protective Measures Problem 1 1
Mechanical Jam 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 103 114
No Known Impact Or Consequence To Patient 14 14
Bruise/Contusion 14 14
Burn(s) 10 10
Bone Fracture(s) 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Abrasion 8 8
Damage to Ligament(s) 6 6
No Patient Involvement 5 7
Laceration(s) 5 5
Pressure Sores 5 5
Fall 4 5
Hematoma 2 2
Injury 2 2
Pain 2 2
Limb Fracture 2 2
Hemorrhage, Subarachnoid 2 2
Superficial (First Degree) Burn 1 1
Death 1 1
Hip Fracture 1 1
Head Injury 1 1
Multiple Fractures 1 1
Suture Abrasion 1 1
Cellulitis 1 1
Cardiac Arrest 1 1
Discomfort 1 1
Numbness 1 1
Nerve Damage 1 1
Insufficient Information 1 1
Muscle/Tendon Damage 1 1
No Consequences Or Impact To Patient 1 2
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Altimate Medical, Inc. II Nov-16-2022
2 Golden Technologies, Inc. II Aug-17-2020
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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