The US Food and Drug Administration (FDA) released a safety alert regarding a Class I recall of the Philips HeartStart MRx defibrillator. The recall was initiated in June 2017 when Philips sent a “medical device correction notification” to affected customers, informing them of the device’s risks.
The gas discharge tube of the device has micro cracks that allow internal gasses to escape and cause the tubes to malfunction. This defect also allows for an electrical current surge to cross the designated resistors, damaging the resistors and preventing the device from functioning while in automated external defibrillator (AED) mode.
The HeartStart MRx could fail at any time, including during delivery of repeated shocks in AED mode or during a periodic operational check, per the device’s instructions for use. The device will not deliver therapy if used in AED mode after failure, and if use continues, serious patient injury or death could result.
It is important to note that the device will continue to work in Manual mode after AED mode failure. However, the electrocardiogram displayed will be “noisy,” which may make for difficult interpretation.
The affected model/item numbers are M3535A and M3536A, manufactured between September 22, 2016 and October 31, 2016 and distributed from September 26, 2016 through November 2, 2016. More information is available online at the FDA.
HeartStart MRx defibrillator by Philips Electronics: class I recall defects in gas discharge tubes may cause device failure [press release]. Silver Spring, MD: US Food and Drug Administration; February 9, 2018.