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 CareEvent [Product code: 866435] & Patient Information Center iX (PIC iX) [Product code: 866389] [HKMD Number: 210175, 150026].
According to the TGA, it was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. The issue occurred on devices running iOS 15, 16 and 17 as well as multiple versions of iPhones.
The Care Assist mobile application is not intended to replace the patient’s primary alarming system. If users rely on the Care Assist application as their primary event notification alarming system, the failure of custom ringtones could result in a delay in treatment for patients experiencing a change in clinical condition.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00183-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 18 Mar 2024
Posted on 11 Mar 2024