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FDA Classifies Trilogy Evo Ventilator Recall as Urgent Due to Software Malfunction

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The recent identification of the Philips Respironics Trilogy Evo continuous ventilator recall as Class I by the FDA underscores the urgency and significance of the issue. This designation comes over a month after the company initiated a voluntary correction in March. The recall pertains to a software issue that poses a potential power malfunction in certain situations.

The Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators are sophisticated medical devices designed to provide essential breathing assistance to patients in need. These devices leverage advanced technology, including a microprocessor-controlled blower, to deliver precise pressure support, pressure control, or volume control during respiratory therapy. This capability is crucial for patients with respiratory conditions, as it helps to ensure adequate oxygenation and ventilation, promoting improved respiratory function and overall well-being.

The decision to recall these ventilators was not taken lightly but rather emerged from Philips’ rigorous post-market surveillance activities and subsequent root cause analysis. This proactive approach underscores Philips’ unwavering commitment to patient safety and quality assurance. By identifying and addressing potential issues promptly, the company aims to mitigate any risks associated with the use of its medical devices and uphold the highest standards of care for patients worldwide.

Philips Initiates Recall of Trilogy Evo Ventilators to Address Software Issue

Through comprehensive surveillance efforts, Philips continuously monitors the performance and safety of its products following their release into the market. This ongoing assessment allows the company to identify any deviations from expected performance or safety standards promptly. In the case of the Trilogy Evo ventilators, the discovery of a software issue necessitated immediate action to address the potential risk it posed to patients.

Root cause analysis, a systematic process for identifying the underlying causes of problems or failures, was conducted to determine the exact nature and scope of the issue affecting the Trilogy Evo ventilators. This thorough investigation enabled Philips to gain a deeper understanding of the factors contributing to the software malfunction and develop targeted solutions to rectify the problem effectively.

By initiating a voluntary recall of the affected ventilators, Philips demonstrates its proactive approach to product safety and quality management. Rather than waiting for adverse events to occur, the company took decisive action to address the issue and minimize any potential harm to patients. This commitment to transparency, accountability, and patient welfare is central to Philips’ mission as a healthcare technology leader.

Ventilator

Philips Urges Software Update for Trilogy Evo Ventilators to Enhance Safety

Moving forward, Philips remains dedicated to ensuring the ongoing safety and efficacy of its medical devices through continued vigilance, innovation, and collaboration with regulatory authorities, healthcare professionals, and patients. By learning from past experiences and leveraging the latest advances in technology and quality management practices, the company strives to uphold its reputation as a trusted provider of life-saving medical solutions.

In March, Philips notified customers through an Urgent Medical Device Correction Notice, urging them to update the ventilators to the latest software version (1.05.06.00). The recall addresses a potential power malfunction that could trigger a “battery depleted” or “loss of power” alarm erroneously, leading to an abrupt interruption in ventilation despite sufficient power availability. However, ventilators with software version 1.05.06.00 installed are not susceptible to this issue.

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The alarms may stop therapy if the device operates solely on battery power or continue therapy if connected to a permanent power source. This malfunction typically occurs when the ventilators operate in CPAP or PSV mode, fail to detect the patient’s respiratory effort for over 10 minutes, and have software versions other than 1.05.06.00 installed. Fortunately, there have been no reports of serious injury or fatalities associated with the recall. Steve Klink, head of global external relations at Philips, emphasized that the software malfunction only occurs under specific circumstances outlined above. Philips continues to work diligently to address the issue and ensure the safety of patients relying on Trilogy Evo ventilators.

 

Resource: Food and Drug Administration, May 13, 2024

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