From the FDA:
Dräger has issued a statement regarding its 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.
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. To
date, there have been no reported injuries or reported failures due to
this issue.
BACKGROUND: This 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 (see firm press
release for information on affected serial numbers by model).
RECOMMENDATION:
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 details
concerning switching to manual ventilation in case of a fault are
provided in the Instructions for Use in the Fault-Cause-Remedy and
Ventilator Fail Safe sections. Hospitals are urged to notify
their personnel accordingly.
