Draeger Issues Correction Due to Manufacturing Error in Anesthesia Workstations

Draeger, Inc. has released a correction through the FDA regarding their Atlan A350 and Atlan 350XL anesthesia workstations.

Until Draeger can replace the ventilator motor assembly, the FDA release recommends that these devices be used with “close, constant supervision.” If mechanical ventilation fails, operators should “ventilate patients manually by switching to manual/spontaneous (Man/Spont) mode.”

An Urgent Medical Device Correction was issued on October 15 concerning the devices. The letter recommended similar steps to the FDA release, and to “make sure all users of the Draeger Atlan and others in the organization with concern for this device know about the notice.” Users were also told to complete a Medical Device Correction Return Response Acknowledgement and Receipt Form attached to the letter.

The letter was sent because of a manufacturing error afflicting the workstations which “may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.” There have been no reported injuries or deaths associated with the error so far. The workstations are “intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. It is used for inhaled anesthesia during surgical or diagnostic procedures.”