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, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., has issued a medical device safety alert concerning its V90 electronic vaporizer (for used with A9 Anesthesia system) [Serial Number: AG4B22000862, AG4C22000819, AG4C22000827, AG4G22000892, AG4G22000897 AG4G22000904, AG4G22000908, AG4B36002292, AG4C25001027] [HKMD No.: 210096].
The manufacturer identified a potential safety issue with 2 batches of V90 electronic vaporizers. The V90 electronic vaporizer is used to deliver inhalation anesthetic agents in the A9 anesthesia system. During use the anesthetic injector of V90 electronic vaporizers may not be sealed tightly, which may potentially result in the output of the anesthetic concentration is higher than the setting value. This can be monitored by the anesthesia system in real-time and will give a relevant alarm such as “Vaporizer Output Abnormal”.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Jul 2024