• 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 mask, oxygen
Regulation Description Oxygen mask.
Product CodeBYG
Regulation Number 868.5580
Device Class 1

MDR Year MDR Reports MDR Events
2015 63 63
2016 22 22
2017 8 8
2018 39 39
2019 29 29
2020 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 52 52
Disconnection 33 33
Inflation Problem 12 12
Detachment Of Device Component 10 10
Connection Problem 9 9
Obstruction of Flow 6 6
Nonstandard Device 6 6
Break 4 4
No Flow 4 4
Kinked 4 4
Loose or Intermittent Connection 4 4
Port 4 4
Partial Blockage 3 3
Fitting Problem 3 3
Incorrect Device Or Component Shipped 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Tube 3 3
Fluid Leak 2 2
Material Separation 2 2
Failure to Unfold or Unwrap 2 2
Device Issue 2 2
Material Twisted/Bent 2 2
Insufficient Information 2 2
Contamination /Decontamination Problem 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Leak/Splash 2 2
Component Falling 2 2
Decoupling 1 1
Restricted Flow rate 1 1
Circuit Board 1 1
Valve(s) 1 1
Bag 1 1
Occlusion Within Device 1 1
Malposition of Device 1 1
Electromagnetic Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Output Problem 1 1
Physical Property Issue 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Out-Of-Box Failure 1 1
Split 1 1
Patient-Device Incompatibility 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration or Expulsion of Device 1 1
Hole In Material 1 1
Valve, Flap 1 1
Air Leak 1 1
Complete Blockage 1 1
Crack 1 1
Filling Problem 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 82 82
No Known Impact Or Consequence To Patient 41 41
No Patient Involvement 28 28
Low Oxygen Saturation 6 6
Tissue Breakdown 3 3
No Information 3 3
Foreign Body In Patient 2 2
Burn(s) 2 2
Dyspnea 2 2
Rash 1 1
Visual Disturbances 1 1
Conjunctivitis 1 1
Airway Obstruction 1 1
Nasal Obstruction 1 1
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Abnormal Blood Gases 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Respiratory Distress 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II May-24-2017
2 Intersurgical Inc II Dec-07-2017
3 POM Medical LLC II Oct-31-2019
-
-