FDA hands down Class I rating to Vyaire Medical's ventilator recall

Software updates are usually rolled out to eliminate any bugs, but, for some of Vyaire Medical’s ventilators, an early 2021 update resulted in a potentially dangerous issue that has caught the attention of the FDA.

According to a notice put out by Vyaire earlier this month, some of its Bellavista ventilators are at risk of malfunctioning if a certain software configuration is in place. The company initiated a voluntary correction for the affected machines at the end of December, and this week the FDA dished out a Class I rating—the agency’s most serious—to the move.

The ventilators are used in hospitals and intensive care facilities to deliver supplemental oxygen into the airway or lungs. They’re designed to be easily transferred throughout a facility to provide respiratory support to a range of patient populations, from newborns to adults.

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The flaw may occur in Bellavista 1000 and 1000e series ventilators that are running at least the software version 6.0.1600.0—which was introduced in February 2021—and have their data communication ports set to “HL7.” When both of these factors are present, they can create what Vyaire describes as a “conflict in memory resource allocation between software tasks.”

If that occurs, it may cause the machine to stop ventilation and emit a technical failure alarm with the “305” label. A sudden, unintentional pause in ventilation could potentially lead to serious adverse events, including death.

However, as long as the communication port isn’t on the HL7 setting, the error won’t occur, so the company said it still “supports the continued use of these devices” once the setting has been disabled.

So far, no deaths have been reported in connection with the software flaw, but the FDA has received 18 complaints and reports of seven injuries linked to the issue.

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The correction spans nearly 4,200 Bellavista ventilators carrying the 1000 and 1000e series that were distributed across the globe between January 2017 and December of last year. In the U.S., more than 2,600 of the ventilators are in use, with distribution beginning in March 2019.

Though not a recall in the literal sense of the word, Vyaire’s corrective action calls for all healthcare facilities using the ventilators to immediately disable the HL7 port until another software update addressing the issue has been released. It expects to have the update ready before the end of March.

In the meantime, the company has put out a software patch to fix the issue in ventilators that are running the affected software version and contain the software option “Data Communication.”