Medical device manufacturer, Philips Medical Systems, issued medical device safety alerts concerning its HeartStart XL+ Defibrillator/Monitor [Model number: 861290).
The manufacturer identified two issues related to the affected product:
Issue 1
The affected products may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, the issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device indicates to the user that it is not ready for use.
According to the manufacturer, a failed restart may result in a delay in therapy if the defibrillator/monitor is needed for immediate use. The device behavior may be caused in some cases by a defect in the HeartStart's memory management software and in other cases by a malfunction of the System On Module (SOM) installed on the Processor printed circuit assembly (PCA). Since 2011, two complaints attributed to these issues on the HeartStart XL+ have involved a patient death.
As a remedy, the manufacturer will perform a system software upgrade and replace the Processor PCA that contains the SOM module that is subject to failure. Until the required parts are available and the service is performed, any XL+ that is observed to reboot itself or fail to start should be removed from service, regardless of whether it is subsequently restarted successfully.
Issue 2
The rotary therapy selector switch of the affected product may fail, resulting in unpredictable device behaviour. These behaviours include:
According to the manufacturer, should one of these behaviours occur, appropriate therapy delivery may be delayed. The manufacturer has not received any reports of deaths resulting from the switch failure.
As a remedy, the manufacturer will install a replacement switch in affected devices. Affected customers are advised to continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use as this reduces the risk of a failure during use. If the affected customers identify a device that exhibit any of these behaviors, remove it from service and contact the manufacturer to request service.
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 18 November 2019