Medical device manufacturer, Philips Medical Systems has issued a medical device safety alert concerning its Efficia Monitor models CM10, CM12, CM100 and CM120. The details of the affected products are as follows:
A problem has been detected in the affected products that makes the touchscreen inoperable. The manufacturer's investigation detected that the failure is related to an improper cleaning process.
According to the manufacturer, when the screen of the monitor is exposed to water or liquids, the touch screen may stop working. Some cleaning process use spray directly on the screen and wipe it with a cloth. According to the Instruction for Use, this is not a permitted process and will cause the issue even in a short period of time depending on the amount and type of the cleaning agent.
There is no risk for the patients or users since the monitor can continue to be operated using the trim knob and membrane buttons.
As a response to the problem, the manufacturer improved the sealing of touchscreen in production procedure for the affected models. It is not expected that the same issue can cause touchscreen failures in the Efficia Monitor CM150 due to different construction characteristics.
The manufacturer will replace the touch screen assembly upon request. Affected users are advised to ensure that their cleaning process is in line with the Monitor Instructions for Use.
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 25 November 2019