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 flowmeter, tube, thorpe, back-pressure compensated
Product CodeCAX
Regulation Number 868.2340
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 1 1
2021 6 6
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 4 4
Crack 4 4
Gas Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembly by Users 2 2
Burst Container or Vessel 2 2
Defective Component 2 2
Free or Unrestricted Flow 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Material Rupture 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Appropriate Term/Code Not Available 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 4 4
Death 4 4
Low Oxygen Saturation 2 2
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
No Information 1 1
Insufficient Information 1 1

-
-