Medical device manufacturer, Philips Medical Systems, has issued a medical device safety alert concerning its Efficia CM10, CM12, CM100, CM120 and CM150 patient monitors [Product Code: 863300, 863301, 863302, 863303, 863304; all manufactured before 25 Oct 2018].
The manufacturer has received a report in which a Philips Efficia Monitor with lithium ion batteries that had exceeded its battery life expectancy and overheated/ignited. These batteries should be replaced when the number of charge-discharge cycles exceed 300 cycles or when the remaining battery capacity is below 80% of that of a new battery, whichever comes first.
According to the manufacturer, overheating of a lithium ion battery may cause the device exterior case to become excessively hot, causing the case to melt and/or the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
Affected customers are advised to take the following actions:
The local manufacturer's representative will visit the sites and assist the affected customers to perform the software upgrade to their Efficia monitors.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 21 January 2019