Medical device maker Draeger Medical has recalled the Evita V500 and Babylog VN500 ventilators after discovering battery issues that could put patient safety at risk.
The U.S. Food and Drug Administration (FDA) classified this as a Class I recall, its most serious category, reserved for situations in which use of the device could result in serious injury or death. The battery problem can lead to an unexpected lapse in ventilation, though the FDA notes that there not yet been any reports of patient harm, MassDevice.com reports.
Draeger discovered the defect through an internal investigation in response to customer complaints about rapid power depletion in the optional PS500 power unit accompanying certain Evita V500 and Babylog VN500 ventilators, MassDevice reports. This recall affects only Evita V500 and Babylog VN500 ventilators equipped with the optional PS500 power supply unit. These models were distributed nationally between June 2011 and January 2014.
Draeger’s investigation revealed that battery capacity was reduced due to the occurrence of sulfation within the battery. Frequent short use of PS500 battery power can increase sulfation, further reducing battery capacity, according to the FDA. When sufficient sulfation occurs, connecting to main power cannot guarantee fully charged batteries and the charge indicator may not reflect battery capacity. In some cases, neither the “Battery Low” nor the “Battery Depleted” alarm was triggered when battery capacity fell below 10 percent. When the battery is totally depleted, ventilation will stop and manual ventilation will be required until the device is connected to main power. This can be especially dangerous when a patient is being transported.
Draeger will replace the PS500 batteries free of charge, but until a permanent solution can be found, the company recommends that users take precautions to minimize the risks. The company recommends using the affected ventilators during transport only if absolutely necessary and not for trips longer than one hour. Draeger also advises against brief battery use and charging. Batteries should be charged for at least 24 hours.
For questions about the recall or the affected ventilators, call Draeger Service Technical Support at 1.800.543.5047 from 8 a.m. to 8 p.m., Eastern Time, Monday through Friday, or by email email@example.com.
Adverse events or quality problems may be reported to the FDA through the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.