Tuesday, July 16, 2024

Ventilator Instructions Updated by Philips Respironics Following Serious Safety Concerns

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Philips Respironics, Inc. has issued an urgent update for the use instructions of its OmniLab Advanced+ (OLA+) Ventilator, prompted by reports of therapy interruptions and/or loss of therapy. The U.S. Food and Drug Administration (FDA) has classified this recall as the most serious type, indicating that continued use of the device without adhering to the updated instructions could result in serious injury or death.

The affected product is the OmniLab Advanced+ Ventilator. This update involves revising the instructions for use rather than removing the devices from their current locations. If therapy interruptions can be tolerated and the ventilator inoperative (vent inop) alarm occurs, patients and caregivers are instructed to remove the patient from the device and place them on an alternative device. For those who cannot tolerate therapy interruptions, it is crucial to provide alternate ventilation and contact the equipment supplier immediately for a replacement device.

Philips Respironics Issues Urgent Actions for OmniLab Advanced+ Ventilator Users

In April, Philips Respironics, Inc. dispatched an URGENT Medical Device Recall notice to all affected customers, outlining several critical actions. If a Ventilator Inoperative Alarm occurs, patients should be promptly removed from the device and connected to an alternative ventilation source, if available. As an optional step, performing a “hard reboot” (a forced device restart) may temporarily restore the device’s function. Customers are also instructed to contact Philips to obtain a software patch addressing the Ventilation Inoperative Alarm issue and to complete and return the response form included in the recall notice.

Philips Respironics, Inc. is revising the use instructions due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips plans to correct the affected OLA+ devices with a software patch or offer replacement devices until the issue is resolved.

The OmniLab Advanced+ Ventilator is prone to entering a Ventilator Inoperative state (therapy stopped, with audible and visual alarms present) after three reboots within 24 hours or even without a preceding reboot. These malfunctions can lead to significant therapy interruption or loss, potentially causing severe health consequences. These include anxiety, confusion, increased or decreased respiratory rate, dyspnea, tachycardia, abnormal chest wall movement, hypoxemia, hypercarbia, hypoventilation, respiratory failure, or in the most severe cases, death. So far, there have been 15 reported injuries and one report of death associated with this issue.


OmniLab Advanced+ Ventilator Recall Highlights Need for Updated Use Instructions and Patient Vigilance

The OmniLab Advanced+ Ventilator aids patients in breathing by providing two different pressure levels, making breathing support more comfortable. The device features Bi-Flex, which reduces pressure during exhalation, and offers various therapy modes including Continuous Positive Airway Pressure, Spontaneous mode, Spontaneous/Timed mode, Timed mode, and Pressure Control modes with optional Bi-Flex or AVAPS. This ventilator is used to treat patients with obstructive sleep apnea, breathing difficulties, and mixed types of apnea. It is suitable for children aged seven and older who weigh more than 40 pounds and for adults weighing more than 66 pounds. The device is intended for use in hospitals and sleep laboratories.

The recall highlights the importance of continuous monitoring and reassessment of medical devices to ensure patient safety. For patients currently using the OLA+ ventilator, it is essential to consult with healthcare professionals to discuss alternative treatment options. Philips Respironics may continue to supply OLA+ ventilators through compassionate use or named-patient programs for those already receiving the therapy. Healthcare professionals are advised not to start any new patients on the OLA+ ventilator outside of clinical trials.

In light of this recall, patients and caregivers should remain vigilant and ensure they are following the updated use instructions. For further information and guidance, it is recommended to speak with healthcare professionals or contact national competent authorities. The FDA’s classification of this recall as the most serious type underscores the critical nature of adhering to the revised instructions to prevent serious injury or death.

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Resource: Food and Drug Administration, June 28, 2024

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