The FDA notified the public last Tuesday of Draeger Inc.’s Class I recall of their Atlan A350 and Atlan 350XL anesthesia workstations. Issued on October 15th, the recall involves an urgent correction of the stipulated devices.
Draeger Inc. initiated the Urgent Medical Device Correction after discovering a manufacturing error that can cause failure of both the piston ventilator and manual ventilator in the Atlan A350 (UDI 04048675556176/8621500) and Atlan 350XL (UDI 04048675556183/8621600) devices. Both devices are used by anesthesiologists to deliver anesthesia during surgery and other medical procedures. The devices provide ventilation support and “inhaled anesthesia” when needed. Customers can find a full list of impacted serial numbers here.
The company plans to complete a “motor assembly replacement” on all of the recalled devices. While waiting for the replacement, Draeger Inc. asks users to follow very specific safety guidelines. To start, the company specifies that the Atlan A350 and Atlan 350 XL should only be used with constant supervision. In the event of motor failure during a procedure, providers can use the manual/spontaneous mode to ventilate patients. Providers must monitor the patient’s oxygenation levels constantly to avoid injury.
Draeger Inc. asks health care providers and facilities to forward notice of the Urgent Medical Device Correction to any potential users of the Atlan A350 and Atlan 350 XL devices. Additionally, all users and/or facilities should complete and return the Medical Device Correction Return Response Acknowledgment and Receipt Form attached to the company’s Urgent Medical Device Correction letter.
While Draeger Inc. has not received reports of injury in connection to the recalled devices, injury may absolutely occur if providers continue to use the Atlan devices without following the updated guidelines. As explained by the FDA, interruption to ventilation can cause low oxygen levels, a disruption to lung recruitment, “slow heart rate (bradycardia), sudden heart stop (cardiac arrest), and death.”
Patients and health care providers can report any new adverse health events related to use of Draeger’s Atlan A350 or Atlan 350 XL devices through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of Draeger’s Atlan A350 or Atlan 30 XL anesthesia workstations, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.