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.
Medical device manufacturer, Philips Medizin Systeme Böblingen GmbH, has issued a medical device safety alert concerning IntelliVue G7m Anesthesia Gas Modules [Model Number: 866173; Serial Number: DE43800129 through DE43812627] [HKMD No.: 140224, 200415, and 220328].
The manufacturer is informing users that a problem has been detected in the Philips IntelliVue G7m Anesthesia Gas Modules, that, if it were to reoccur, could affect the performance of the equipment. The 866173 IntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m’s sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion.
With the announcement of the technical INOP alarm, it becomes obvious to the user that the device has stopped working, which can trigger one or more of the following INOPs:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Mar 2023