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 continuous ventilator, minimal ventilatory support
Definition A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.
Product CodeQOR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Tidal Volume Fluctuations 1 1
Contamination /Decontamination Problem 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Unspecified Infection 1 1
Low Oxygen Saturation 1 1

-
-