Last month’s recall of nearly 50,000 HeartStart MRx Monitor/Defibrillators wasn’t the first time Philips Healthcare has faced scrutiny over its emergency cardiac defibrillators. In January, Bloomberg News reported that the company was in talks with the U.S. Department of Justice (DOJ) over a civil matter involving the Food & Drug Administration.
The issue is apparently related to inspections of the Philip Healthcare devices leading up to 2013. During a news conference, the company’s CEO, Frans van Houten, said that the matter hadn’t resulted in any legal action, and was unrelated to a 2013 FDA warning regarding faulty HeartStart models. However, Philips Healthcare acknowledged that it was expecting this latest issue to have a “meaningful impact” on the operations of the business.
On February 24, Philips Healthcare announced a recall for certain HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The recalled devices could also unexpectedly stop pacing. The action affected 47,362 units nationwide that were manufactured from February 11, 2004 to November 4, 2016, and distributed from February 12, 2004 to November 4, 2016. The following model numbers were included: M3535A (M3535ATZ), M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
The failure of a HeartStart MRx Monitor/Defibrillator to deliver needed therapy could result in serious patient injury, including brain injury, organ damage or death. The FDA announced last week that it had designated the matter a Class I recall, it s most serious recall category.
In 2009, Philips recalled about 5,400 of its HeartStart FR2+ AEDs after discovering a microchip failure that could render the device inoperable.
In September 2012, Philips Healthcare announced a recall for 70,000 HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs after determining that an internal electrical component in the devices could fail. This occurrence could cause the AED to incorrectly indicate that it is ready for use. At the time, the FDA designated the action a Class II recall, after determining that the chance of serious patient injury or death was remote.
In a November 2013 follow-up, Philips provided customers with updated information about a faulty electrical component that could cause the previously recalled AEDs to fail to deliver an appropriate shock. According to CBS News , Philips had been unable to contact about 22% of those who had purchased an AED involved in the 2012 recall, and was urging those who still had a device in their possession to contact the company for a replacement.