Urgent safety information for the LUISA ventilator.

Last updated 19.12.2023

Identification of the medical devices affected:Ventilators of the series LUISA, TIVAN LS, LifeOne (LM150TD)
All serial numbers are affected here.

Below you will find all the important information and measures relating to the safety information described above.

Description of the problem including the cause identified

In rare cases, an internal communication problem between the ventilator’s controllers may result in ventilation being discontinued without the issue of an alarm. From a technical perspective, these communication problems may occur in all firmware versions available in the market. In the market, the occurrence was only observed in firmware version 1.7.0003. Four potentially serious incidents have become known in the market in which this problem has occurred. To date Löwenstein Medical Technology has not received any reports of harm to patients in this context.

Measures

Measures to be taken by the addressee:

• Please immediately inform your staff, affected patient, customers and users about the potential risk.
• You should update all LUISA, TIVAN LS, LifeOne (LM150TD) ventilators to a firmware version 1.9.0007 or higher within 6 months.
• Please use an additional monitoring system to monitor patients if the therapy of patients dependent on ventilation with the above-mentioned ventilators is to be continued until updating of the device. For example, continuous pulsoximetric (SpO2) monitoring or monitoring of the carbon dioxide level (CO2) on exhalation can be used here as an additional monitoring system.
• Where an affected ventilator with the above fault picture has failed, the therapy can be commenced again by restarting the device. After restarting, check that the home display is shown. Then hold down the on/off key until the therapy starts again. This process can take up to 30 seconds. After restarting the ventilator, there is no increased probability that the fault picture will re-occur multiple times with the same device.

Measures taken by Löwenstein Medical Technology:

Löwenstein Medical Technology has issued a firmware update with revision 1.9.0007 which eliminates the cause of the fault picture described above. The update, which additionally includes other quality improvements, will be made available to all users free of charge. This firmware update also implements measures from the safety information dated May 2023 for the above ventilators with the use of accessories for invasive ventilation.

Update 1.9.0007 essentially comprises the following points:

• Iimproved trigger settings in single circuit with valve
• Additional setting option in user interface and notification in regards to necessary alarm settings

• Improved description of circuit test and calibration of accessory line
• New design of the trend views
• In addition: SpO2 measurement with Nonin Xpod

For quick access to the mandatory update V 1.9.0007, please use this link: Firmware (loewensteinmedical.de)

Information on the new firmware update V 1.9.0007.

Watch the following video to find out more about the modifications and functions of the new LUISA firmware update.

Do you have any questions or require further information?

Please get in touch with your contact person.