Cardiac Science calls defibrillators home for corrections
Cardiac Science has initiated a voluntary field correction of several automated external defibrillators (AEDs), saying the devices contain a component that may fail due to a manufacturing defect.
The device’s self-test may not detect the problem to head it off and, if the component were to fail during a rescue attempt, the AED may not deliver adequate defibrillation therapy, Cardiac Science said. Such a failure would interfere with resuscitation of the patient, raising the obvious risks attached to such a scenario.
Cardiac Science alerted its customers to the problem in January, instructing those with affected devices to return them for correction at the factory. The affected units were manufactured between July 1, 2011, and Dec. 30, 2011.
The company stated that its standard quality-control processes caught the issue before any reports of device failure came in from users. It also pointed customers to an online serial number search to determine if a given device is affected.
The device’s self-test may not detect the problem to head it off and, if the component were to fail during a rescue attempt, the AED may not deliver adequate defibrillation therapy, Cardiac Science said. Such a failure would interfere with resuscitation of the patient, raising the obvious risks attached to such a scenario.
Cardiac Science alerted its customers to the problem in January, instructing those with affected devices to return them for correction at the factory. The affected units were manufactured between July 1, 2011, and Dec. 30, 2011.
The company stated that its standard quality-control processes caught the issue before any reports of device failure came in from users. It also pointed customers to an online serial number search to determine if a given device is affected.