The Food and Drug Administration (FDA) on Feb. 9 alerted health care providers to a recall of the Philips HeartStart MRx defibrillator because of small cracks in the device’s glass discharge tube.
The cracks allow internal gases to escape and can cause the tubes to malfunction. An electrical current surge can damage the defibrillator’s designated resistors and prevent it from working in automated external defibrillator (AED) mode. Although the defibrillator will continue to work in manual mode after AED mode failure, the electrocardiogram on the device may be noisy and challenging for the provider to interpret.
The recall affects devices with model numbers M3535A and M3565A that were distributed from Sept. 26 to Nov. 2, 2016. FDA advises health care professionals to report adverse reactions or quality problems associated with these products to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Contact Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.