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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
Product CodeINO
Regulation Number 890.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTIMATE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DALTON INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DESIGN SPECIFIC FLETCHER
  SUBSTANTIALLY EQUIVALENT 1
DESIGN SPECIFIC LTD
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 16 16
2015 23 23
2016 35 35
2017 38 38
2018 38 38
2019 37 41
2020 41 44
2021 49 49
2022 29 33
2023 29 29
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 212 212
Fire 23 23
Break 13 13
Electrical /Electronic Property Problem 11 15
Mechanical Problem 9 13
Smoking 8 8
Use of Device Problem 7 7
Device Alarm System 7 7
Adverse Event Without Identified Device or Use Problem 7 7
No Audible Alarm 6 9
Device Operates Differently Than Expected 6 6
Device Tipped Over 4 4
Material Too Rigid or Stiff 4 4
Unintended System Motion 4 4
No Apparent Adverse Event 4 4
Unintended Movement 3 3
Device Slipped 3 3
Material Protrusion/Extrusion 2 2
Sparking 2 2
Patient-Device Incompatibility 2 2
Improper or Incorrect Procedure or Method 2 2
Overheating of Device 2 2
Loss of Power 2 2
Component Falling 2 2
Mechanical Jam 2 2
Insufficient Information 2 2
Protective Measures Problem 2 2
Patient Device Interaction Problem 2 2
Device Fell 2 2
Device Handling Problem 1 1
Noise, Audible 1 1
Scratched Material 1 1
Temperature Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Contamination 1 1
Loose or Intermittent Connection 1 1
Bent 1 1
Detachment Of Device Component 1 1
Product Quality Problem 1 1
Self-Activation or Keying 1 1
Inadequate Service 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Component Missing 1 1
Failure to Align 1 1
Defective Device 1 1
Battery Problem 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 81
No Known Impact Or Consequence To Patient 68 68
No Code Available 44 44
Injury 21 21
Fall 19 21
Bruise/Contusion 17 17
Bone Fracture(s) 13 13
No Patient Involvement 13 19
No Information 11 11
No Consequences Or Impact To Patient 10 11
Burn(s) 10 10
Death 8 8
Abrasion 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Laceration(s) 6 6
Pain 6 6
Pressure Sores 6 6
Head Injury 4 4
Hematoma 2 2
Hemorrhage, Subarachnoid 2 2
Damage to Ligament(s) 2 2
Hip Fracture 2 2
Fracture, Arm 1 1
Malaise 1 2
Numbness 1 1
Loss of consciousness 1 1
Suture Abrasion 1 1
Physical Entrapment 1 1
Discomfort 1 1
Superficial (First Degree) Burn 1 1
Multiple Fractures 1 1
Muscle/Tendon Damage 1 1
Insufficient Information 1 1
Nerve Damage 1 1
Fainting 1 1
Rash 1 1
Sprain 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Weakness 1 1
Concussion 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Contusion 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 Invacare Corporation II Aug-17-2013
4 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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