Medical device manufacturer, Philips Health Systems, has issued a medical device safety alert concerning its Efficia DFM100 Defibrillator/ Monitor [Model Number: 866199, Units Affected: World Wide devices with certain configurations only: AED Only, AED+SpO2, AED+CO2 or AED+SpO2 +NBP].
The manufacturer has identified the possibility that, on rare occasion, the affected devices, when powered-on in AED mode, may stop operating and reboot. Rebooting could result in a delay of therapy of approximately 23 seconds. As a remedy, the manufacturer is releasing a new software version to prevent this situation.
The affected users are advised to upgrade device software to the latest version S-453564462801-REL Rev. 2.00.14 or greater, and contact the manufacturer if the device fails to function as intended.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Oct 2018