Safety information regarding a possible interruption of treatment / Astral 100/150 ventilators New
In this letter, the Federal Office for Health Safety (BASG) draws attention to a potential risk posed by Astral 100 and Astral 150 ventilators manufactured by ResMed. Specifically, the products affected are those manufactured before October 2024 and with serial numbers lower than 22241890149.
According to the manufacturer, the following risk exists: the manufacturer has identified that, in certain Astral ventilators, a component – known as a supercapacitor – may develop a leak over time. In rare cases, a leak from this component may damage internal parts of the ventilator and cause the device to be incorrectly placed into a so-called ‘safety mode’. If this problem occurs during treatment, ventilation may be unexpectedly interrupted. If the ventilator is in standby mode, ventilation may not start.
For further information and details of the measures to be taken by the user, please refer to the manufacturer’s enclosed patient information leaflet.
| Medical devices | Astral 100 and Astral 150 ventilators and their corresponding mainboards. |
|---|---|
| Manufacturer | Resmed |
| Batch number(s) | The above-mentioned products that were manufactured before October 2024 |
| Serial number | less than 22241890149 |
| BASG reference number | 9003897463 |
| Company letter (pdf) Link | Patientenbrief des Herstellers |
