Sign up for the QMED & MD+DI Daily newsletter.
Philips Respironics Corrects Trilogy Ventilators Software, Use Instructions
The company said the software updates and IFU addendum will resolve multiple safety issues reported.
2 Min Read
.png?width=1280&auto=webp&quality=95&format=jpg&disable=upscale "Philips")
AFP / Stringer / AFP via Getty Images
Philips Respironics recently announced a mandatory software correction and updates to its instructions for use (IFU) for the Trilogy Evo, EV300, Evo02, and Evo Universal ventilators to resolve several safety issues that could affect the device’s ability to support patient breathing.
The trilogy ventilators are used to provide support, pressure control, or volume control during breathing support. There have been several previously reported safety issues, as well as new issues, that the software update will resolve, according to the company, including:
Inaccurate display of oxygen delivered to a patient where the patient may receive less than indicated on the device screen.
A software issue causing false power loss or battery depleted alarms which could lead to therapy being suddenly stopped.
Inaccuracies related to flow sensor reading compensation associated with volume measurement.
Software alarm errors — obstruction alarm, high and low tidal volume alarms when using A/C-VC mode, leakage alarm, and nuisance alarms.
HIP/LIP – HEP/LEP technical alarm threshold to eliminate nuisance alarms.
Addition of high priority vent service required alarm criteria to detect contamination on flow sensor mesh.
E110 vent INOP issue triggered by motor stalls.
Spontaneous breath percent calculation.
Floating point calculations.
Translation strings to avoid confusion for customers.
User interface issues.
Adjustment of maximum alarm volume setting to meet standards requirements.
Software errors, as well as data corruption and transfer of data with care orchestrator and care orchestrator essence.
Additionally, the devices will also be corrected using the company’s user manual addendum L1154778b03, Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, & Trilogy EV300 Clinical & Caregiver Manual Addendum to include the accumulation of environmental debris on the internal machine flow sensor, which could potentially partially block pressure, volume, or air flow; IFU translations in Korean, Spanish, and Chinese languages; and missing contraindications in the IFU.
Philips has received nine reports of injury, and one death associated with these issues.
The company is recommending that healthcare providers not operate the Trilogy ventilators without making sure that the software has been successfully updated to version 1.05.10.00 (US), and that they are aware of the user manual addendum.
About the Author
You May Also Like
.svg?width=700&auto=webp&quality=80&disable=upscale)
.png?width=700&auto=webp&quality=80&disable=upscale)
