Medical device manufacturer, Draeger Medical Systems Inc, has issued a medical device alert concerning its Infinity Acute Care System (IACS); Infinity M540 Stand Alone Patient Monitor with M540 Revision Indexes 24-29.
According to the manufacturer, this medical device may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. If this error continues and reboots three times in a time span of 10 minutes, it will enter a fail-state. The M540 will reset to factory default and users will need to manually configure and readmit the patient to continue patient monitoring.
The manufacturer stated that there were no reported cases of patient impairment. Affected users can still use the system by paying special attention to the described situation.
The manufacturer will contact affected users to schedule software upgrade once it becomes available.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 30 December 2020