Philips Gets FDA Warning Letter Involving Defibrillators

Philips Gets FDA Warning Letter Involving Defibrillators

April 15th, 2011 // 1:28 pm @

Royal Philips Electronics NV (PHIA.AE) has received a U.S. Food and Drug Administration warning letter citing inadequate responses to issues with the company’s emergency defibrillators, including problems linked to deaths.

The letter to Philips said the FDA found multiple violations during an inspection at the company’s Seattle facility last year. The letter also addressed issues with the company’s quality processes.

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Philips said Wednesday it has significant changes underway in response to the FDA inspection, and that any added moves needed to address the warning letter ” should be readily accomplished.”

The Dutch company also said the letter — issued in late March — isn’t expected to cause any disruptions in shipments.

The FDA letter noted multiple Philips defibrillator problems, such as an issue with detached or missing magnets that has generated 87 complaints since early 2008, including one patient death. The FDA said Philips’s responses missed the mark because “they do not address the quality system observation indicating that no evaluation of the effectiveness of the corrective action was performed or documented.”

In another case, the agency said there was an August 2009 complaint involving a death when a defibrillator failed to operate during an attempted rescue. That device had previously failed multiple tests, and while Philips has process- related changes to limit such events, the company “has not provided any evidence of implementation of these changes,” the FDA said.

Additionally, the FDA said Philips failed to report to the agency quickly enough when the company became aware its devices may have caused or contributed to patient deaths, among other issues.

The devices in question are automated external defibrillators, or AEDs, which are designed to detect and treat potential deadly heart-rhythm problems. The letter involved “HeartStart,” “FRx,” “FR2+,” and “HS1” products.

Warning letters can sometimes prove costly and time consuming to remedy. The FDA can also block approval for new, related devices until all the issues are addressed and the letter is lifted.

The FDA letter noted multiple instances where Philips responses have adequately addressed problems, but also other areas where the company came up short. Philips, in a statement, said it is committed to continuous improvement of its quality and compliance processes.

“In this spirit, Philips has been cooperative and responsive to all of the FDA’s requests, from the beginning of the inspection onward, providing detailed responses and documents to the FDA during and after the inspection,” the company said.

Philips said it will submit a written response to the FDA’s letter by Monday including more quality-system documentation and records. It will also bring on an independent consultant as requested to certify the Seattle facility’s quality systems meet FDA regulations.

The consultant’s certification is due by September, after which Philips expects the FDA to conduct a follow-up inspection.

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