U.S. FDA warns of flaw in some Philips defibrillators

Reuters

Dec 4 (Reuters) - U.S. regulators have warned that someautomated external defibrillators made by Philips MedicalSystems may be unable to deliver potentially life-saving shocksto the heart in emergency situations, due to an electronicproduct malfunction.

The U.S. Food and Drug Administration, in a safety advisoryposted on the agency's website, provides recommendations on howto better inspect and monitor readiness of the previouslyrecalled HeartStart AEDs.

Many of them remain in schools, shopping malls, medicaloffices, sports clubs and private homes, available for use byemergency responders to jolt the heart back into normal rhythmin victims of sudden cardiac arrest.

Philips, a unit of Dutch electronics company Royal PhilipsNV, in August 2012 voluntarily began notifying itscustomers that some of its more than 600,000 devices, almosthalf of them located in the United States, might fail to workproperly due to a flawed internal electrical component.

The FDA the following month declared a Class II recall onthe devices, citing a "remote" chance of severe adverseconsequences or death due to the product flaw.

FDA spokeswoman Jennifer Rodriguez said the agency issuedits safety advisory on Tuesday because Philips has been unableto reach a significant number of its customers, to point out thepotential risk.

"A lot of devices could be affected and we want to make surepeople are aware of this safety issue," Rodriguez said.

The FDA recommends that users, including consumers and firstresponders, contact Philips immediately for a replacement AEDunit.

"Philips has not received any reports of patient harm due tothis issue," company spokesman Mario Fante said in an emailedstatement on Wednesday.

"There have been 61 devices taken out of service for repairor replacement due to this issue, out of the 605,000 deployedworldwide," Fante said.

Fante said the devices, through an automated periodicself-test feature, create an audible "triple-chirp alert" if theelectrical problem exists.

In that event, customers are advised to call companyrepresentatives immediately, Fante said. If the triple chirp isheard during emergency use, customers are advised to follow allvoice instructions provided by the device.

The AEDs were distributed between 2005 and 2012 and soldunder the brand names HeartStartFRx, HeartStartHome andHeartStartOnsite.

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