The FDA Wednesday issued a recall notice for Draeger Medical‘s Evita V500 and Babylog VN500 ventilators due to an issue with the batteries not appropriately displaying its charge.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall relates to an error with the ventilators in which the battery does not last as long as expected, according to the FDA. The battery indicator light on the units show as sufficiently charged even when the battery is depleted, the agency said.
The ventillators do not indicate how much time is left for the battery when “battery low” and “battery depleted” alarms sound, according to the FDA, though Draeger indicated it should be approximately 30 minutes. If the ventilator shuts down, the patient may not receive necessary oxygen which could lead to injury or death.
The recall affects 2,081 units with catalog numbers 8416400 and 8417400. The affected units were manufactured and distributed between June 1, 2011 and June 30, 2015, according to the FDA.
The federal watchdog said Draegar began notifying customers of the issue in July and advised them to not rely on the battery level indicator, provide manual ventilation if the power fail alarm sounds, and advised against using the device for patient transportation unless necessary.
The FDA recalled the same Draeger ventilators last April over similar issues with the power and batteries.