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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device patient bed with canopy/restraints
Definition Enclosed bed canopy system used as passive restraint.
Product CodeOYS
Regulation Number 880.6760
Device Class 1


Premarket Reviews
ManufacturerDecision
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
Insufficient Information 4 4
Torn Material 4 4
Use of Device Problem 4 4
Product Quality Problem 4 4
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Deformation Due to Compressive Stress 2 2
Failure to Align 2 2
Difficult to Open or Close 1 1
Misassembled During Installation 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Device Damaged Prior to Use 1 1
Physical Property Issue 1 1
Crack 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Positioning Failure 1 1
Dent in Material 1 1
Loose or Intermittent Connection 1 1
Escape 1 1
Inadequate or Insufficient Training 1 1
Nonstandard Device 1 1
Failure to Advance 1 1
Bent 1 1
Device Handling Problem 1 1
Material Perforation 1 1
Structural Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Malposition of Device 1 1
Material Frayed 1 1
Disconnection 1 1
Cut In Material 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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