Early Alert: Anesthesia Machine Issue from Draeger, Inc.
Draeger, Inc. is issuing a correction for additional anesthesia workstations following a manufacturing error that could lead to ventilator failure before or during clinical use.
This alert affects Draeger, Inc., healthcare facilities utilizing Draeger anesthesia workstations, and clinical staff responsible for ventilator operation and maintenance.
Failure of an anesthesia ventilator during a procedure presents an immediate risk to patient ventilation and oxygenation. The source indicates a manufacturing error as the root cause, which may necessitate an internal audit of production quality controls and suggests that previous corrective actions may not have fully addressed the scope of the issue.
Facility risk management and clinical engineering teams should identify and isolate affected Draeger workstations. Quality departments should document the correction in accordance with post-market surveillance and CAPA requirements, while clinical leads should ensure back-up ventilation is available for all active anesthesia cases until equipment integrity is verified.
Draeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.
Open in openFDA / FDA.gov