FDA Announces Recall of Respironics Ventilator

The US Food and Drug Administration (FDA) and Respironics California, Inc, have notified healthcare professionals regarding the class 1 recall of a mechanical ventilator (PLV Continuum Ventilator [PLVC I]) due to the potential for device failure resulting in serious injury or death.
The problem has been linked to a design flaw that can cause breakage of lead wires in the air flow valve during use, according to an alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program.
In a news release, the company notes that no adverse events or injuries have been reported as a result of the flaw. .The FDA advises that patients be safely transferred from the device to a different comparable patient support device. If a suitable ventilator is not available, arrangements for a substitute device can be made by contacting the company by phone at 1-760-918-7328.
The ventilator is used in homes and in institutional and portable settings to provide invasive and noninvasive ventilation for pediatric and adult patients weighing 5 kg or more; it is not intended for use as an emergency transport ventilator.

source: Medscape


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