U.S. regulators have warned that some automated external defibrillators made by Philips Medical Systems may be unable to deliver potentially life-saving shocks to the heart in emergency situations, due to an electronic product malfunction.
The U.S. Food and Drug Administration, in a safety advisory posted on the agency's website, provides recommendations on how to better inspect and monitor readiness of the previously recalled HeartStart AEDs.
Many of them remain in schools, shopping malls, medical offices, sports clubs and private homes, available for use by emergency responders to jolt the heart back into normal rhythm in victims of sudden cardiac arrest.
Philips, a unit of Dutch electronics company Royal Philips NV, in August 2012 voluntarily began notifying its customers that some of its more than 600,000 devices, almost half of them located in the United States, might fail to work properly due to a flawed internal electrical component.
The FDA the following month declared a Class II recall on the devices, citing a "remote" chance of severe adverse consequences or death due to the product flaw.
FDA spokeswoman Jennifer Rodriguez said the agency issued its safety advisory on Tuesday because Philips has been unable to reach a significant number of its customers, to point out the potential risk.
"A lot of devices could be affected and we want to make sure people are aware of this safety issue," Rodriguez said.
The FDA recommends that users, including consumers and first responders, contact Philips immediately for a replacement AED unit.
"Philips has not received any reports of patient harm due to this issue," company spokesman Mario Fante said in an emailed statement on Wednesday.
"There have been 61 devices taken out of service for repair or replacement due to this issue, out of the 605,000 deployed worldwide," Fante said.
Fante said the devices, through an automated periodic self-test feature, create an audible "triple-chirp alert" if the electrical problem exists.
In that event, customers are advised to call company representatives immediately, Fante said. If the triple chirp is heard during emergency use, customers are advised to follow all voice instructions provided by the device.
The AEDs were distributed between 2005 and 2012 and sold under the brand names HeartStartFRx, HeartStartHome and HeartStartOnsite.
First published December 4 2013, 12:52 PM