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TPLC
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Device
patient bed with canopy/restraints
Definition
Enclosed bed canopy system used as passive restraint.
Product Code
OYS
Regulation Number
880.6760
Device Class
1
Premarket Reviews
Manufacturer
Decision
J. T. POSEY CO.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
53
53
2015
9
9
2016
7
7
2017
6
6
2018
15
15
2019
16
16
2020
6
6
2021
5
5
2022
28
28
2023
7
7
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
34
34
Material Separation
30
30
Mechanical Problem
26
26
Detachment Of Device Component
13
13
Device Operates Differently Than Expected
8
8
Component Missing
7
7
Material Integrity Problem
6
6
Product Quality Problem
4
4
Torn Material
4
4
Insufficient Information
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Appropriate Term/Code Not Available
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Defective Component
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Deformation Due to Compressive Stress
2
2
Tear, Rip or Hole in Device Packaging
2
2
Failure to Align
2
2
Patient Device Interaction Problem
2
2
Material Split, Cut or Torn
2
2
Misassembled During Installation
1
1
Positioning Failure
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient-Device Incompatibility
1
1
Dent in Material
1
1
Material Perforation
1
1
Structural Problem
1
1
Material Puncture/Hole
1
1
Bent
1
1
Device Handling Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Physical Property Issue
1
1
Device Damaged Prior to Use
1
1
Crack
1
1
Detachment of Device or Device Component
1
1
No Apparent Adverse Event
1
1
Failure to Advance
1
1
Malposition of Device
1
1
Nonstandard Device
1
1
Inadequate or Insufficient Training
1
1
Escape
1
1
Difficult to Open or Close
1
1
Loose or Intermittent Connection
1
1
Cut In Material
1
1
Material Frayed
1
1
Disconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
52
52
No Clinical Signs, Symptoms or Conditions
39
39
No Known Impact Or Consequence To Patient
35
35
Fall
11
11
No Patient Involvement
7
7
Insufficient Information
3
3
Cardiac Arrest
2
2
Injury
2
2
Fracture, Arm
1
1
Death
1
1
Not Applicable
1
1
Respiratory Arrest
1
1
Bone Fracture(s)
1
1
Abrasion
1
1
Hemorrhage, Subdural
1
1
Physical Entrapment
1
1
Limb Fracture
1
1
Airway Obstruction
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sensory Medical Inc
I
Apr-14-2022
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