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
2014 1 1
2015 2 2
2017 4 4
2018 3 3
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
Burst Container or Vessel 3 3
Gas Output Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembly by Users 2 2
Appropriate Term/Code Not Available 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Material Separation 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Free or Unrestricted Flow 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Excess Flow or Over-Infusion 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unsealed Device Packaging 1 1
Detachment Of Device Component 1 1
Use of Incorrect Control/Treatment Settings 1 1
Air Leak 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Low Oxygen Saturation 5 5
Death 5 5
No Consequences Or Impact To Patient 2 2
Bradycardia 1 1
Cardiopulmonary Arrest 1 1
No Information 1 1
Insufficient Information 1 1

-
-