Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 regulator, pressure, gas cylinder
Regulation Description Pressure regulator.
Product CodeCAN
Regulation Number 868.2700
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 6 6
2022 6 6
2023 19 19
2024 59 59
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 27 27
Fire 6 6
Gas/Air Leak 6 6
No Flow 4 4
Insufficient Information 3 3
Explosion 3 3
Overheating of Device 3 3
Defective Component 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misassembly by Users 2 2
Output Problem 1 1
Defective Device 1 1
High Readings 1 1
Key or Button Unresponsive/not Working 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Device Handling Problem 1 1
Incorrect Measurement 1 1
Device Emits Odor 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1
Medical Gas Supply Problem 1 1
Appropriate Term/Code Not Available 1 1
Failure to Cycle 1 1
Nonstandard Device 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1
Inaccurate Information 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Insufficient Information 22 22
Low Oxygen Saturation 8 8
Superficial (First Degree) Burn 2 2
Cardiac Arrest 2 2
Burn(s) 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
No Known Impact Or Consequence To Patient 1 1
Dyspnea 1 1
Bradycardia 1 1
Cough 1 1
Convulsion/Seizure 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Western/Scott Fetzer Company II Apr-12-2023
2 Western/Scott Fetzer Company II Nov-19-2021
-
-