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.
During post marketing surveillance, the Department of Health received report that the information showed on the packaging of the device bearing the listing number [HKMD 190344] i.e. “Asante PO40 Finger Pulse Oximeter” (picture provided below) is inconsistent from those approved by the Medical Device Administrative Control System i.e. “Hunan Accurate Bio-Medical Technology Pulse Oximeter FS20D” (https://www.mdd.gov.hk/en/mdacs/search-database/list-md/index.html?page=details&id=190344).
The Local Responsible Person (LRP) has informed the Department that “Asante PO40 Finger Pulse Oximeter” is equivalent to “Hunan Accurate Bio-Medical Technology Pulse Oximeter FS20D” in terms of technical specifications, manufacturer, safety, performance and quality. There is no identified health risk or hazard associated with the issue. The manufacturer advises affected users to continue to use the captioned device without taking any further actions. The LRP is going to rectify the corresponding labelling in due course.
No adverse event or patient harm has been reported to the Medical Device Division of the Department of Health due to the issue to date.
The LRP has issued a field safety notice regarding the issue on their website. For further information, please visit https://www.healthcarehk.com/2022/05/16/field-safety-notice-of-asante-po40/
If you are in possession of the affected products, please contact the LRP at 2810 4868 for enquiry.
Posted on 16 May 2022