Australian Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Invacare Platinum Oxygen Concentrator, manufactured by Invacare. The affected model numbers are IRC9LXO2AWQ , IRC5LX02AW, IRC5LXAW.
The manufacturer has learned that the Pressure Sensitive Interrupter (PSI) design for the compressor motor start/run capacitor by one supplier could lead to rupture. That capacitor in the oxygen concentrator has an internal pressure relief component (the PSI) which may not operate as intended permitting the capacitor to rupture in certain circumstances.
These capacitors were utilised in production from March 2010 to August 2012 at one of their manufacturing sites.
If the PSI does not function to relieve the heat and pressure due to a short circuit within the capacitor, then the pressure can cause a rupture in the seam between the housing and the end plate. If the rupture occurs, the oil may be expelled from the capacitor which may result in a fire hazard.
The manufacturer is providing instruction on how to identify if an affected capacitor is present in the oxygenator. If present, end users are requested to contact their distributor to arrange for a technician to replace the capacitor.
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00383-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 May 2015