Previous Daily Updates

Updated June 1, 2020

  • Preliminary Pneumatic and Electronic Assembly instructions as well as Preliminary Bill of Materials for final design have been uploaded to their respective sub-pages. We estimate that we will update throughout the week as we continue to document the construction of the remaining build items.
  • The interactive review process with the FDA to obtain Emergency Use Authorization of our PanVentTM Emergency Use Ventilator is underway.

Updated May 28, 2020

  • Pneumatic Assembly Instructions and updated Bill of Materials are currently being developed.  We estimate that these will be completed and available on our website Monday June 1st, 2020
  • The interactive review process with the FDA to obtain Emergency Use Authorization of our PanVentTM Emergency Use Ventilator is underway.

Updated May 15, 2020

  • The Goodyear PanVent #1 ventilator has been cycling for 347 hours or 14.4 days at a respiratory rate of 30; that is 624,000 breaths.
  • We submitted test, performance and safety data, and other documents to the FDA today for review towards Emergency Use Authorization of our PanVentTM Emergency Use Ventilator. Our manufacturing partners are The Goodyear Tire & Rubber Company, LifeMech and Sonic Manufacturing Technologies.

Updated April 18, 2020

Topic: Continuing to develop and localize an open source ventilator (Ventilator A) AND applying for U.S. Food and Drug Administration Emergency Use Authorization of a fixed-design ventilator (Ventilator B)

Samsun Lampotang, PhD, FSSH, FAIMBE; April 18, 2020

We thank all of you who have been following and assisting with our pandemic ventilator development. We now have two ventilator designs, which may have engendered confusion and the misperception that we are abandoning our open source concept and focusing only on the United States to the detriment of other countries. This update is to clarify that we remain committed to the open source ventilator concept and helping countries outside the U.S. while applying for Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA).

Ventilator A is an open source, open architecture design that will be localized using parts that are readily available locally and that adhere to the open architecture concept.

Ventilator B is a fixed-design ventilator similar to the open source design that we will use to apply for EUA from the FDA. If we receive authorization, Ventilator B can then be used in the United States if it is needed.

Rationale for two ventilator designs and obtaining EUA for Ventilator B:

The state of New York was an early test site of the open source pandemic ventilator concept and its intended use in patients positive for COVID-19. Private citizens in New York built our ventilators. We were communicating with these volunteers but it became clear that our ventilator design would not be used in New York without receiving EUA from the FDA.

Learning from the New York experience, we assumed that EUA approval would be required in all 50 American states. Therefore, we submitted a pre-EUA application to the FDA last week and have since had formal meetings with the FDA. We plan to collect data and the documentation needed to submit our full EUA application for the fixed-design Ventilator B by the end of April.

In parallel to working on the EUA submission for fixed-design Ventilator B, work continues on open source Ventilator A, and outreach and response to countries outside the United States. You can read about our efforts at growing a global support network for pandemic ventilators. The University of Florida International Center has now joined us in coordinating our international outreach efforts that include India, Bangladesh and South Africa.

With added work from two parallel ventilator designs, we would appreciate additional help from volunteers. You can volunteer by contacting us.  Thank you. Stay well.

Updated April 17, 2020

  • At noon today, a ventilator (the one on our live cam feed) has been ventilating a test lung continuously for 3 weeks

Updated April 16, 2020

  • We apologize for the recent lack of daily updates. The team is focused on submitting our Emergency Use Authorization (EUA) application to FDA for a fixed design ventilator.
  • Endurance testing continues: multiple solenoid valves have now passed the 1,000,000 cycles threshold with one exceeding 1.5 M cycles
  • Open source ventilator: Video of assisted breath in response to a simulated spontaneous inspiratory effort
  • UF Health News published an update on the project:

April 7, 2020; 21:10 EDT

  • An Orbit Model 57280 clocked 900,000 cycles today
  • Two “bicycle inner tube” exhalation valves passed the 350,000 cycles mark today. An alternate exhalation valve design is being built by a volunteer
  • We will use the Bosch BMP280 automotive pressure sensor as the electronic airway pressure sensor to add safety features to the base design
  • A pre-EUA application was emailed to FDA a few minutes ago

April 5, 2020; 9:35 EDT

  • We plan on submitting a pre-EUA letter by Tuesday April 7, 2020 to the FDA for Emergency Use Authorization (EUA) of our ventilator design
  • We plan on submitting the EUA application on Friday April 10, 2020
  • Electronic pressure and flow sensors are being integrated into base design
  • Alarms based on pressure and flow sensors are being finalized

April 3, 2020

  • Complete set of materials for building OS-Vent 1.2 (orifice plate flow restrictor instead of shutoff valve with blue handle) uploaded
  • Build instructions for DIY test lung uploaded
  • Video of design localization effort in Mauritius (replaced Arduino by Trane BMS – Building Management System controller) uploaded
  • Engineering specifications v 1.6 uploaded with displayed alarm messages for 16 character display

No update posted on April 2, 2020

April 1, 2020

  • Our global OS-Vent support network is growing – see world map by clicking on Design Localization link
  • We released today a build document on how to build an exhalation valve with 233,000 cycles MTBF (Mean Time Between Failure) based on our ongoing endurance testing. The desired MTBF is 1,000,000 cycles (a little above 3 weeks of non-stop ventilatory support at 30 bpm). If you can improve the exhalation valve design to reach an MTBF of 1,000,000 cycles, please share the design
  • We released the design so others can build a working ventilator and help us collect test data towards an EUS (Emergency Use Authorization) that we can use for our submission to FDA
  • We started testing an OS-Vent ventilator with pure oxygen as the supply gas today. Previous tests were with medical grade air up to today

No update posted on March 31, 2020

 March 30, 2020

  • Spanish translation added
  • Build instructions (excluding exhalation valve) uploaded
  • Third ventilator assembled in 30 minutes and being endurance tested on live cam
  • One controller unit is timing the operation of two independent ventilators – shared timer instead of shared ventilator in a twist on ventilator sharing; two lungs of different compliance being ventilated independently at same frequency and I:E – see live cam
  • A ventilator independently built from our site information by a ham radio operator in Wisconsin

March 29, 2020

  • The bill of materials was uploaded today – please start localizing the components with a release status of OK (green background in the Excel spreadsheet). The bill of materials is incomplete because we want to do further testing of the exhalation valve. Outside the US, prioritize finding a local equivalent to component G1 (the green solenoid controlled on/off valve in our videos)
  • UF Mech. & Aerospace Engineering Dept. built an OS-Vent1 ventilator and is testing it
  • The University of Florida has created a fund for online donations to support our OS-Vent Open Source Ventilator project.
  • Additional companies are offering to manufacture OS-Vent ventilators free of charge
  • We are making progress on OS-Vent 2 (same pneumatic PVC layout but with electronic pressure and flow sensors and as a result different software running on Arduino

March 28, 2020

  • Design Validation: We have a working BASE OS-Vent ventilator since a successful full system integration on March 27, 2020. Now we pivot to verifying if the BASE design is SAFE. We started endurance testing of controller #2 and Arduino software at 10:30 am on Friday, March 27, 2020 of the BASE OS-Vent model. The pneumatic portion of the ventilator has been running continuously since 12:15 pm on March 26, 2020 at 30 breaths per minute to accelerate testing. The same ventilator has now run without fail overnight for 3 nights in a row. You can view live the endurance testing of that OS-Vent Unit 1 via a live cam feed at a link below.  We pray that the virus will not overtake us and force us to release the test and build instructions before endurance testing is complete. In this crisis, it is important as never to have transparency so that those who choose to test and build our open source ventilator design do so with as much data as we can provide. In this exceptional crisis, the need for transparency in our testing overrides the concern of the ventilator failing publicly on live cam. A volunteer expert has supplied us with a traceability matrix of our OS-Vent design that we will start to populate to help with design validation.
  • Logistics Network: We started an OS-Vent Network of support centers in the US. Our first support center is a College in Minneapolis, MN. The US support centers will coordinate local build efforts, local materials sourcing and coordinate with local hospitals similar to overseas support centers. Two support centers outside the US are already being formed (Lima and Bangladesh).
  • Volunteers/Offers of Free Manufacturing. We thank all the volunteers who have contacted us and offered to help. We have not done a good job managing the outpouring of support and in some cases responding to the offers. We apologize for that. Please know that the offers of help and free manufacturing have been huge morale boosters for the team. We will eventually get back to you and ask you to continue to be patient in the meantime. This Daily Update is an attempt to update everyone instead of replying to individual emails
  • EUA Application. A firm specializing in FDA approvals has agreed to help our team pro bono to start applying for Emergency Use Authorization (EUA) from FDA. We will start that process next week.
  • Bill of Materials. Many of you especially outside the USA are asking us for build instructions now that we have a working prototype. We want to complete at least a minimum of safety testing to ensure our base design is safe while balancing the urgency of an approaching surge. We are releasing today or early tomorrow an INCOMPLETE bill of materials (BOM) that will allow those who want to build our open source ventilators to start gathering the parts and to also localize the components we are using to equivalent components that are readily available locally. The materials left out are the parts we redesigned that we want to test further to ensure they continue to be reliable.
  • Local testing. We will first upload testing instructions so that you can verify that the part you built meets our minimum specifications as workmanship and availability of parts and tools will vary worldwide.
  • Build instructions. We will release FULL build instructions when design validation is complete or if the surge overtakes us, we will release sooner. We will release build instructions for individual modules as they are validated.

March 27, 2020

Sem Lampotang, PhD, FSSH on behalf of the Open Source Ventilator Network

  • Full system integration (including Arduino-based user interface) was conducted today. The BASE system passed preliminary testing. We will post videos of the test of the integrated BASE system soon.
  • Now that we know that the integrated system works, we will test in the next 2 weeks to see if it is safe before releasing the detailed build and test instructions and bill of materials
  • BASE model has been ventilating test lung overnight 2 nights in a row without failure
  • Multiple companies throughout the US have offered free manufacturing of the OS-Vent as well as private individuals
  • Groups in Bangladesh and Peru are working on localization of the components (replacing what we use in the current OS-Vent design by equivalent components that are readily available locally)
  • Faculty and students at the College of Engineering at the University of Florida are redesigning some components
  • Printed circuit board (PCB) – Chinese manufacturer has OS-Vent PCB design and is ready to mass produce
  • Pressure sensor to be used in extension of BASE model has been identified and integrated in a proof of concept model
  • Specifications have been altered to meet or exceed COVID ventilator specifications from UK
  • Added additional disclaimers to the site
  • OS-Vent site translated to French, Italian, Portuguese, Turkish
  • Exploring preliminary steps to obtain Emergency Use Authorization (EUA) from FDA

Stay well. Stay indoors.