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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Löwenstein Medical Technology, Ventilators of the LUISA, TIVAN LS, Life One (LM150TD) series [HKMD No.: 220028].
According to the MHRA, the manufacturer stated that when the ventilator is used, the circuit system must be calibrated with different accessories such as filters and tube extensions up to the patient connection port. If changes are made to the linking of accessories by changing products or adding accessories, a new circuit test is required to determine the resistance of the system, among other things. When a disconnection occurs at the patient connection port, a disconnection alarm is reliably triggered if the circuit test has been performed to calibrate the system beforehand. Disconnection at the patient connection port with accessories that have not been calibrated cannot be clearly detected for reasons involving the linking of accessories. In the event of disconnections beyond the patient connection port, during decannulation of a patient for example, a disconnection may not be detected and the alarm may not be reliably issued.
For further information, please visit https://mhra-gov.filecamp.com/s/d/0YGIINYc6YFVVJd7
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Jun 2023