Inspiration Ventilator Recall Issued Over Risk of Unexpected Shutdown
Federal health regulators warn that potential problems with several models of eVent Inspiration Ventilators may cause the device to malfunction and suddenly shut down, posing a serious injury risk for patients.
An eVent Inspiration ventilator recall was announced this week by the FDA, following at least one report of the power board failing, which could cause the ventilator to shut down without sounding any alarm.
The eVent medical ventilators are designed to provide constant breathing support to infants and adults in serious medical situations. If the ventilator shuts down, the patient may not receive enough oxygen and can suffer serious health side effects, including injury, brain damage, coma or death.
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Given the serious risk associated with the device, the action has been categorized as a class 1 medical device recall. However, there have been no injuries or deaths reported as a result of the problem.
The recall impacts about 251 eVent Medical Inspiration Ventilators LS, 5i, and 7i models sold in the U.S., which were manufactured prior to January 21, 2015 and distributed from February 14, 2013, to December 31, 2014.
Event Medical company warned all healthcare providers and patients using the eVent Inspiration LS, 5i and 7i ventilators by issuing a field safety notice that was sent on October 13, 2015. The notice advises all customers and healthcare providers to immediately discontinue use of the effected ventilator models until corrective actions can be taken. The company also sent instructions for users to remove the faulty component from the power board.
A class 1 recall is the most serious type of recall the FDA can issue, indicating that the agency has determined that use of the medical device may carry a high probability of causing serious injury or death to patients..
For more information about the recall or to report an incident or injury to the FDA contact the FDA MedWatch adverse event reporting program or call the eVent Medical company at (949) 900-1917.
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