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TPLC
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show TPLC since
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2024
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Device
chair, positioning, electric
Product Code
INO
Regulation Number
890.3110
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALTIMATE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
DALTON INSTRUMENT CORP.
SUBSTANTIALLY EQUIVALENT
1
1. K131909
DALTON LIFT CHAIR
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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