The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning the following products manufactured by GE Healthcare:
The manufacturer has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. A loose blender knob shaft may potentially affect the accuracy of the blended output of air/ oxygen gas mixture from the unit which could result in hypoxia or hyperoxia.
The manufacturer advises users to perform a blender accuracy check as outlined in the service manual to verify the oxygen concentration set at 21% and 100% settings are within the recommended range.
If the blender accuracy test results do not meet specification, users are advised to remove the system from patient use and contact the manufacturer. If the blender accuracy results pass, the system is suitable for continued use. However, the manufacturer recommends that a pulse oximeter should be used to monitor the patient when delivering oxygen.
The manufacturer will correct all affected systems as a permanent fix.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01334-1
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 20 December 2013