Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Medical Systems Philips Efficia CMS200 Central Monitoring Station and the Efficia CM100, CM10, CM120, CM12 and CM150 [Multiple product numbers] [HKMD No.: 150349].
According to the TGA, Efficia CM100 through CM150 have four software defects in versions C.00, C.01.00 to C.01.02, version 4.0.0.0 and the fourth issue affects all software versions.
Issue 1: When receiving more than one alarm at the same time without a unique identifier, the Central Station only displays the first alarm, even if the second one is of higher priority.
Issue 2: The AUDIO OFF icon might not be presented even if that parameter is in the AUDIO OFF mode.
Issue 3: The AUDIO OFF icon of the temperature parameter is prevented from being displayed properly at the CMS200 Rev. 2.3 when a non-default temperature label is being used.
Issue 4: When there is a failure of the field-programmable gate array component, there can be parameter values which disappear, physiological alarms can stop generating visual or auditory signals, technical alarms may or may not be generated or the monitor can disconnect from the central station.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00847-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Jul 2022