# China NMPA Product Recall - Siesta i Whispa

Source: https://www.globalkeysolutions.net/records/china_product_recall/dameca-as/58eb4b71-2ae5-43a4-9dfd-42e14232d0d6/
Source feed: China

> China NMPA product recall for Siesta i Whispa by Dameca A/S published January 27, 2015. Recall level: Level II. Philips (China) Investment Co., Ltd., on behalf of manufacturer Dameca A/S, initiated a voluntary Cl

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls anesthesia machines
- Company Name: Dameca A/S
- Publication Date: 2015-01-27
- Product Name: Siesta i Whispa
- Recall Level: Level II
- Recall Reason: When a patient's airway is connected to an anesthesia machine and receiving mechanical ventilation, in volume-controlled mode, if the patient has a large spontaneous breathing movement that occurs during volume control and the ventilator's inspiratory flow rate is higher than 4.5 L/min, the patient's spontaneous breathing may generate a high negative airway pressure. This pressure is limited by the mechanical negative pressure limiter (NPL) valve. If the patient generates a negative pressure of -5 to -7.5 cmH2O (hPa), the NPL valve will open. The trigger value for the NPL valve to release negative airway pressure is set at an inspiratory flow rate of 3.5–4.5 L/min; if the patient generates a flow rate higher than 4.5 L/min, the NPL valve will continue to function, but the airway pressure will still decrease due to airflow resistance and the time it takes for the airflow to reach the patient. The higher the flow rate generated by the patient, the greater the risk of negative airway pressure.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Dameca A/S
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/dameca-as/c020bb9e-2076-42e5-8348-9fcba7f701cd/