Medical device manufacturer, Draeger Medical GmbH has issued a medical device safety alert concerning Infinity Acute Care System (IACS) in Neonatal Mode using software versions VG2.0.3 and higher.
It was found in a laboratory test that when a low SpO2 (yellow) medium grade alarm was provoked and then paused by the user by using the alarm pause function, the device did not generate the SpO2 (red) high grade life threatening SpO2 low alarm on the cockpit or central station when the SpO2 value was further decreased to reach the set alarm limit for the high grade life threatening SpO2 alarm.
The correct SpO2 value was indicated on all devices and the manufacturer is not aware of any incidents during use on patient. Draeger is developing a software upgrade to fix the defect. Meanwhile, Draeger advises the users not to pause the yellow SpO2 low alarm without adequate patient monitoring.
According to the local supplier, the affected products were distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 November 2013