Special Alerts

Medical device manufacturer, Therapy Equipment Limited has issued a medical device safety alert concerning its oxygen flowmeters [Product Code 9505, 9555; Product description: 0-15LPM Diamond Flowmeter; Serial Numbers: 298230 to 355746; Batch/Lot Numbers: 157379 to 171941].

According to manufacturer, when the device is set to flow rates of 2 litres per minute or lower, it has been identified that over a short period of time the flow may reduce to zero. This is a result of an issue with the tolerance parameters affecting the spindle and it’s inter-relationship with other internal components.

The manufacturer advised:

• to identify and quarantine any flowmeters exhibiting the issue, and return those products to Therapy Equipment Limited for the company to undertake a factory-fitted replacement to the spindle component;
• the affected users not to use affected devices at flow rates of 2 litres per minute or less until a replacement spindle has been fitted.

According to the local supplier, the affected product is distributed in Hong Kong, including the public hospital. A press release issued by Hospital Authority on 12 Feb 2023 is attached https://www.info.gov.hk/gia/general/202302/12/P2023021200332.htm?fontSize=1

If you are in possession of the affected products, please contact the supplier for necessary actions.

Posted on 13 Feb 2023