• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device patient bed with canopy/restraints
Definition Enclosed bed canopy system used as passive restraint.
Product CodeOYS
Regulation Number 880.6760
Device Class 1

MDR Year MDR Reports MDR Events
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
Material Separation 23 23
Mechanical Problem 20 20
Break 12 12
Product Quality Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Deformation Due to Compressive Stress 2 2
Improper or Incorrect Procedure or Method 2 2
Appropriate Term/Code Not Available 2 2
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 2 2
Misassembled During Installation 1 1
Device Handling Problem 1 1
Material Perforation 1 1
Defective Component 1 1
Dent in Material 1 1
Patient-Device Incompatibility 1 1
Crack 1 1
Positioning Failure 1 1
Material Frayed 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Consequences Or Impact To Patient 19 19
Insufficient Information 2 2
Physical Entrapment 1 1
Not Applicable 1 1
Respiratory Arrest 1 1
Limb Fracture 1 1
Abrasion 1 1
Airway Obstruction 1 1
Fall 1 1
Bone Fracture(s) 1 1

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