Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: WEINMANN Medical Technology VENTIlogic LS ventilators

14 Jan 2014

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning VENTIlogic LS ventilators, manufactured by WEINMANN Medical Technology. Details of the affected products are as follows:

In extremely rare cases, a diode has failed due to an overload resulting from a voltage surge on the power board. This led to the ventilator failing, meaning that the patient's respiratory support was no longer guaranteed. The manufacturer has modified the layout and components of the affected power board to eliminate the possibility of future occurrence of this fault. Devices which are currently in use for life-support ventilation among critical patients have priority and will be corrected by the manufacturer as quickly as possible.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON362312

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 14 January 2014

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