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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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 34 34
Material Separation 30 30
Mechanical Problem 25 25
Detachment Of Device Component 13 13
Device Operates Differently Than Expected 8 8
Component Missing 7 7
Material Integrity Problem 6 6
Torn Material 4 4
Product Quality Problem 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 2 2
Deformation Due to Compressive Stress 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Align 2 2
Failure to Advance 1 1
Dent in Material 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Cut In Material 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Inadequate or Insufficient Training 1 1
Difficult to Open or Close 1 1
Escape 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Bent 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Crack 1 1
Positioning Failure 1 1
Disconnection 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Misassembled During Installation 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 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 38 38
No Known Impact Or Consequence To Patient 35 35
Fall 11 11
No Patient Involvement 7 7
Insufficient Information 2 2
Injury 2 2
Cardiac Arrest 2 2
Death 1 1
Abrasion 1 1
Airway Obstruction 1 1
Bruise/Contusion 1 1
Bone Fracture(s) 1 1
Hemorrhage, Subdural 1 1
Physical Entrapment 1 1
Fracture, Arm 1 1
Not Applicable 1 1
Respiratory Arrest 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sensory Medical Inc I Apr-14-2022
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