Draeger Altan Correction Cites Mechanical Ventilation Failure

Draeger’s correction of its Atlan A350 and A350 XL anesthesia workstations were recently deemed Class I by FDA. The correction pertains to the potential of the device to experience a mechanical ventilation failure.

The Atlan A350 and A350 XL anesthesia workstations are used in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing, according to the company. The workstation is intended to be used for inhaled anesthesia during surgical or diagnostic procedures.

Draeger is correcting the workstations after finding a manufacturing error that could cause the piston ventilator to fail before use or mechanical ventilation to fail during use.

If failure were to occur, it could result in hypoxia, lung recruitment, bradycardia, cardiac arrest, and death. Currently, there’s been no injuries or deaths connected to the issue.

Contacting affected customers on Oct. 15, Draeger said a representative will be in contact to arrange for a ventilator motor assembly replacement. Until replaced, however, the company said to continue to use the devices under permanent supervision, and, if the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate patients as needed and monitor patient’s oxygenation status as “a brief cessation of ventilation can potentially lead to injury,” according to the recall notice.

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Additionally, Draeger said healthcare providers can downgrade the alarm priority of “ventilator error” to “alarm reset” after switching to the Man/Spont ventilation mode.