The FDA today said it expanded its recall of Draeger Medical‘s Evita V500 and Babylog VN500 ventilators to include the optional PS500 batteries after they were updated with new power supply firmware that failed to correct the issue depleting the battery.
The original recall, initiated last September and updated in December, put the ventilators on Class I recall status due to an 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.
A Class I recall is the most serious type of recall issued by the FDA, indicating “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The ongoing issue with the PS500 power supplies could cause the ventilator to shut down expectedly, cutting off necessary oxygen to the patient and possibly resulting in patient injury or death.
The recall affects units with catalog numbers 8416400 and 8417400 manufactured between June 1, 2011 and December 1, 2015, and distributed between June 1, 2011 and January 31, 2016. A total of 2,501 units are being recalled, distributed to 45 states, Washington D.C. and Puerto Rico, according to the FDA recall notice.
Draeger said it will replace the affected PS500 power supply units.
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.