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 Respironics has issued a medical device safety alert concerning its SimplyGo portable oxygen concentrator [HKMD No.: 130311] and the Repair Kit [Part number: 1093443B].
The manufacturer has identified a potential failure of SimplyGo Oxygen Concentrator and sieve caps built between July 27, 2021 – Jan 18, 2022 if the concentrator is used on a continuous flow setting of 2 for 2,000 hours of operation, the caps could fail over time, resulting in an oxygen leak. When the oxygen leak begins, the compressor will compensate for the drop in pressure. However, once the crack propagates, a low O2 alarm will sound and eventually the unit will no longer function. It is possible that this failure will happen during the standard warranty period (2 years), depending on patient use.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Nov 2022