The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom and The Health Canada have posted a medical device safety alert concerning Respironics V60 Ventilator which is manufactured by Respironics California, Inc., a division of Philips Healthcare.
A review of manufacturing data found that certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. The V60 ventilator will alert users to malfunctioning blowers by annunciating audible and visual alarms. This manufacturing issue has been corrected.
Philips has received two reports of blower motor failures in V60 ventilators to date. While there have been no reports of patient injury, Respironics California, Inc. is replacing all affected blower motors that may have improperly-seated impellers on its V60 ventilators.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm,
and the following Health Canada website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 August 2012