FDA: Class I Recall for Over 47,000 HeartStart MRx Monitor/Defibrillator Units
The agency says the affected devices may have electrical and battery connection issues that can prevent powering up, charging, and use.
The US Food and Drug Administration (FDA) is classifying a recent safety notice covering certain models of the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues as a Class I recall. More than a dozen model numbers of units manufactured between 2004 and 2016 are included in the action.
The manufacturer, Phillips Healthcare, issued a Field Safety Notice last month warning customers of the “possibility of abnormal device behaviors” with the HeartStart MRx. These include poor electrical connection if the pins that connect the battery to the device become damaged or full of debris. The device also may not power on, or it may repetitively reboot when the device is on battery power only. Additionally, when operating with a single battery as the sole source of power, error messages may be displayed, and the device may be either unable to deliver shock therapy or will cease to pace without warning. These abnormal behaviors will continue until the unit is reset. Philips says it is “evaluating both software and hardware changes to prevent this abnormal device behavior.”
The Field Safety Notice provides information on how to inspect the battery connector pins and urges that all staff trained in use of the defibrillator review the information on corrective actions they should take to prevent harm to patients.
The FDA says 47,362 units are affected by the recall nationwide. A class I recall is the FDA’s most serious category, covering situations in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
US Food and Drug Administration. Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly. https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm548491.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: March 24, 2017. Accessed on: March 24, 2017.