Specific Fabius anesthesia machines manufactured by Dräger were recalled as a result of an internal investigation into devices that did not pass the high voltage test portion of the final production test. The recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013 and May 2013 and distributed in the United States between March 2013 and June 2013. Affected devices were distributed nationally.
Investigations determined that on some power supply units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained.
In extreme cases, the influence of mechanical forces – such as movement of the device, for example – may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe