The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a Field Safety Notice concerning Practix33plus, manufactured by Philips Medical Systems.
From recent evaluations, the manufacturer have identified a potential issue in Practix33plus that the welding seam of the tube support arm assembly might be imperfect, leading to a potential risk for a collapsing support arm. There is a potential for a serious injury of persons in case the support arm falls down on a patient's body.
The manufacturer requested the customer to check the system for the safety flange. When there is no "safety flange" installed, the device is potentially at risk. When this flange exists the product is safe. In case there is no flange installed, the welding seams of the arm should be thoroughly checked for possible cracks by an experienced technician. In case of any cracks, immediately stop further operation of the system. Philips will install the safety flange at all systems involved.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON185586
As a voluntary, precautionary measure and in advance of full details of an incident being made available, the manufacturer has decided to recall potentially affected breathing circuits and replace these with circuits which use an alternative form of retainer made from metal.
As a precaution until affected stock can be replaced, users are advised to confirm the absence of loose fragments of heater wire retainer inside the heated limb(s), referring to figure 1 of the field safety notice for guidance.
For details, please refer to the MHRA website as below:
http://www.mhra.gov.uk/Safetyinformation/ Safetywarningsalertsandrecalls/fieldsafetynotices/CON185586
If you are in possession of the products, please contact your supplier for information and necessary actions.
Posted on 3 October 2012