Recalls

FDA recalls ventilators due to life threatening errors

preemie baby 435x293 FDA recalls ventilators due to life threatening errorsThree ventilators are being recalled due to defects that could cause serious injury or death to patients.

The battery on the PS500 Power Supply Unit on Evita V500 and Babylog VN500 Ventilators manufactured by Drager Medical do not last as long as expected. The battery indicator light shows a sufficiently charged battery 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.

An analysis conducted by Drager indicates that the battery should last about 30 minutes. If the power is lost, the 30-minue battery back-up should last until the ventilator is connected to a main power supply.

The Evita V500 Ventilator provides constant breathing support for adults and children, including babies weighing at least 14 ounces. The Babylog VN500 provides constant breathing support for babies weighing at least 14 ounces.

The Puritan Bennett 980 Ventilator by Coviden also is being recalled, because when the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (called tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, he or she may need to be removed from the ventilator and placed on a different system.

The Puritan Bennett 980 (PB980) Ventilator System provides constant breathing support for adults, children and premature babies weighing at least 10.6 ounces.

All three of the recalled ventilators are used in hospitals or during patient transport.

Any adverse events or quality control issues with these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA – Evita and Babylog
FDA – Puritan Bennett