# China NMPA Product Recall - BiPAP autoSV Advanced System One ventilator, BiPAP autoSV ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/respironics-inc/cb0a3b9a-a35f-494c-aef5-c8d563af45a3/
Source feed: China

> China NMPA product recall for BiPAP autoSV Advanced System One ventilator, BiPAP autoSV ventilator by RESPIRONICS, INC. published June 01, 2015. Recall level: . Philips (China) Investment Co., Ltd. issued a voluntary recall, reported to the National Medical Pro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling ventilators (BiPAP autoSV Advanced System One and BiPAP autoSV models).
- Company Name: RESPIRONICS, INC.
- Publication Date: 2015-06-01
- Product Name: BiPAP autoSV Advanced System One ventilator, BiPAP autoSV ventilator
- Recall Reason: ResMed, a company in the industry, has issued an urgent field safety bulletin indicating that patients randomly assigned to the ResMed matched servo ventilation (ASV) treatment group had a statistically significant 2.5% absolute increase in the annual risk of cardiovascular mortality compared to the control group. In patients with reduced left ventricular ejection fraction (LVEF ≤ 45%), the annual cardiovascular mortality rate was 10.0% in the ASV treatment group, compared to only 7.5% in the control group, resulting in a relative increase of 33.5% in the risk of cardiovascular mortality (HR = 1.335, 95% CI = (1.070, 1.666), p-value = 0.010). Philips is actively evaluating and carefully analyzing the information provided by ResMed to determine the potential impact of this situation on the treatment of patients using the aforementioned Philips devices. Prior to the completion of our investigation, based on RcsMcd's announcement, we strongly recommend that clinicians follow these recommendations: Do not administer ASV to new patients with symptomatic chronic heart failure (NYHA class 2–4), LVEF reduction ≤45%, or moderate to severe central sleep apnea. Heart failure assessment should be performed on patients before initiating ASV treatment. Objective LVEF assessment should be performed to prevent the development of signs and symptoms of heart failure. If a patient currently receiving ASV treatment is found to be in a high-risk group, the patient should be evaluated and the need to discontinue ASV treatment should be discussed. If it is uncertain whether a current patient is in a high-risk group, the patient should be evaluated to determine whether ASV treatment should continue. No adverse reaction risks have been identified in other patient populations.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: RESPIRONICS, INC.
- Summary: Philips (China) Investment Co., Ltd. issued a voluntary recall, reported to the National Medical Products Administration (NMPA) on June 1, 2015, for its BiPAP autoSV Advanced System One and BiPAP autoSV ventilators. This action stemmed from an industry safety bulletin, specifically from ResMed, highlighting an elevated cardiovascular mortality risk associated with similar servo ventilation (ASV) devices. The key issue identified is a statistically significant 2.5% absolute increase in annual cardiovascular mortality risk, which rose to 10.0% for patients with symptomatic chronic heart failure (NYHA class 2-4) and reduced left ventricular ejection fraction (LVEF "\u2264" 45%). No adverse risks were found in other patient groups. Philips is actively assessing the implications for its own devices under the NMPA's framework. Required actions include advising clinicians to avoid initiating ASV treatment for new high-risk patients. For existing patients, an objective LVEF assessment is mandated, with those in high-risk categories requiring evaluation to consider discontinuing ASV. Philips will disseminate customer notification letters and press releases to distributors, who are responsible for informing prescribing physicians and affected patients.

Company: https://www.globalkeysolutions.net/companies/respironics-inc/d4ef75c4-b7e8-4456-8214-116210f986d5/