China NMPA Product Recall - Siesta i Whispa

Philips (China) Investment Co., Ltd., on behalf of manufacturer Dameca A/S, initiated a voluntary Class II recall for its "Siesta i Whispa" anesthesia machines. This action, reported to the National Medical Products Administration (NMPA) on January 6, 2015, and publicly announced on January 27, 2015, addresses a critical safety concern. The primary issue occurs when patients receiving mechanical ventilation in volume control mode exhibit strong spontaneous breathing movements and the ventilator's inspiratory flow rate exceeds 4.5 L/min. Under these conditions, a high negative airway pressure can be generated, potentially leading to patient discomfort. While a mechanical negative pressure limiter (NPL) valve is present, its optimal function is for flow rates below 4.5 L/min, making it less effective at higher spontaneous flow rates. The recall affects 21 units globally. As required actions, Philips is distributing a "Field Safety Notice" and an updated instruction manual appendix to all affected customers, ensuring comprehensive user notification. Additionally, the company recommends considering supportive ventilation modes like VSV or PSV for patients with strong spontaneous breathing to prevent negative airway pressure.