Fabius Anesthesia Machines: Recall
MedSun: Newsletter #89, November 2013

FDA MedWatch Safety Alert

Dräger issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. 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. 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. To date, there have been no reported injuries or reported failures due to this issue. If users of the Fabius anesthesia machines experience such a failure of the automatic ventilation function, they should switch over to the manual ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob, and start manual ventilation.

Additional Information:

Fabius Anesthesia Machines: Recall. FDA MedWatch Safety Alert. October 23, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370844.htm


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