Dräger has expanded its recall to 2,501 units of its PS500 optional power supply units that were updated with new software.
The new software failed to correct the issue depleting the battery, so Dräger will now replace all affected PS500 power supply units, according to an FDA notice.
The optional battery power supply is sold for use with the Dräger Evita, designed for breathing support for children and adults, and Babylog ventilators, built for premature babies weighing at least 14 ounces.
“The ongoing PS500 power supply issue could cause the ventilator to shut down unexpectedly. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death,” the FDA says.
Dräger became aware of cases in which the battery capacity of the optional PS500 power supply unit for the Evita Infinity V500, Evita V300 and Babylog VN500 was rapidly and unexpectedly reduced despite using the most recent power supply software (FW1.50) released in November 2015, says company spokeswoman Marion Varec.
“According to our findings, the new power supply firmware (FW1.50) doesn’t represent an improvement. Therefore, the decision was made to cancel the distribution of the updated power supply software (FW1.50) and to downgrade devices on which this software version is already installed,” she tells IDDM.
Affected products in the original recall were distributed from June 1, 2011 through Oct. 30, 2015. The expanded recall extends the distribution date to Jan. 31 of this year.