Medical device manufacturer, WEINMANN Emergency Medical Technology GmbH + Co. KG, has issued a medical device safety alert concerning its MEDUCORE Standard2 monitor/defibrillator WM 45300 [Affecting all serial numbers up to and including SN 1494].
When the device starts up, it may not start properly and then display a device fault (display goes yellow) or the screen may stay switched off. In this case, the "device fault" alarm is output after approximately 30 seconds. This means that the device is not ready for use at that point. The device will generally start if the device is started up again, it then also remains ready for use.
According to the manufacturer, this is caused by a timing fault in the software in conjunction with the wiring. If the device cannot be started up at the first time when it is switched on, this can lead to a delay to therapy.
The following remedies must be performed:
Users can continue using the affected products until the remedial measures described have been performed, but affected users should be aware that they should start up the device again immediately if the first attempt is unsuccessful. The affected users do not need to decommission the device.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 January 2020