Urgent safety information.

For LUISA, TIVAN LS, LifeOne (LM150TD) ventilators.

Status: 07-29-2024

Identification of the medical devices affected: Ventilators in the LUISA, TIVAN LS, LifeOne (LM150TD) series.
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 exceptional rare cases, an initialization problem with the ventilator's internal acoustic alarm system may result in only the visual alarm signal being emitted but not the acoustic alarm signal. This only occurs at alarm volume 1. When using alarm volume 2 or higher, a visual as well as an acoustic alarm is guaranteed. The ventilator is delivered with an alarm volume of 2 set as standard.

From a technical point of view, this initialization problem can occur with firmware versions up to version 1.9.0016.

There are 2 known incidents from the market where this problem occurred at alarm volume 1. This corresponds to a percentage probability of occurrence of 0.00008% (with around 22 million potential uses). To date Löwenstein Medical Technology has not received any reports of harm to patients in relation to this issue.

Measures.

Measures to be taken by the addressee:

Please immediately inform your staff, affected patients, customers, and users about the potential risk.
Until the firmware update is available, ensure that the device is always used with an alarm volume of 2 or higher. Detailed instructions on how to change the alarm volume are attached to the following letter. You can also find these instructions in the following video.
You should update all LUISA, TIVAN LS, LifeOne (LM150TD) ventilators to firmware version 1.13.XXXX or higher by April 2025. The update is expected to be available in October 2024.

Measures taken by Löwenstein Medical Technology:

Löwenstein Medical Technology will release a firmware update to rectify the cause of the error described above. The update, which also includes other performance improvements, will be made available to users free of charge. The firmware update is expected to be available in October 2024.