|Dräger Evita Infinity V500|
The FDA warned of a Covidien ventilator that may not deliver enough air, and another one from Dräger Medical that has faulty batteries. The ongoing corrective actions of about 2,700 units of the devices have been deemed Class 1, a designation reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The FDA lists recalls in a database, but also issues more prominent warnings about selected corrective actions that it wants to draw attention to.
The agency warned that Dräger Medical's Evita Infinity V500 and Babylog VN500 ventilators have batteries that do not last as long as expected, and that the indicator light shows the device is sufficiently charged even when the battery is depleted.
"When the 'battery low' and 'battery depleted' alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death," the FDA said.
The problem puts patients who are being transported at particular risk because that is when the device is not connected to the main power supply. In July, Dräger Medical sent customers a letter informing them of the problem. It recommended test the battery before patient transport, and not using the ventilator for patient transport if there are less than two hours left on the battery.
All batteries will be replaced free of charge.
All lots of the device are affected by the corrective action. That amounts to 2,081 units distributed across the U.S.
According to the recall database, the devices were also recalled last year because the battery in the power supply unit did not last as long as expected.
In addition, Covidien's Puritan Bennett 980 Ventilator System may deliver less air than specified by a clinician when the device is in neonatal Volume Control Plus mode with active ventilation due to a software issue, the FDA said.
The PB 980 ventilator is used in hospitals and patient transport. On July 17, Covidien sent customers a letter indicating that it will implement a software update. Until then, the company recommended notifying users about the problem, and transferring patients to an alternative ventilator when it is safe to do so, especially if the device is being used with NeoMode feature in only pressure control modes.
According to an August 14 notice in the FDA's recall database, 657 units of the PB 980 are recalled across the U.S. The PB 980 is also distributed in various countries, including Colombia, Egypt, Kuwait, Panama, Slovenia and South Africa.