Medical device manufacturer, Edwards Lifesciences, has issued a medical device safety alert concerning its EV1000 Databox and Monitor [Model number: EV1000A].
The safety alert reinforces the proper set up of the external power supply according to the equipment operator manual. The manufacturer has recently been notified about an electrical fire that initiated at the power supply of one of the EV1000A system due to noncompliant system installation configuration which caused fluid ingress to the power supply. The manufacturer is not removing product from commercial distribution.
The manufacturer is informing all affected users with EV1000A systems to confirm compliance of installation configuration against the current requirements documented in the Operator's Manual section EV1000 Power Adapter Mounting Bracket.
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 30 May 2016