The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning portable ventilators Legendair™ and Supportair™ manufactured by Covidien.
According to Covidien, a failure component identified as capacitor C53 may cause the ventilator not to start up or not to run on internal battery. The ventilator will run on external battery or A/C mains power instead.
Covidien recommends including the replacement of the C53 capacitor as part of the revised annual preventive maintenance. The initial replacement of the component should occur no later than the next scheduled maintenance and should then be replaced annually as part of the preventative maintenance schedule.
According to the local supplier, the affected products have been distributed in Hong Kong. For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 22 May 2012