When a medical device doesn’t work as it’s meant to, it puts patients’ lives at risk. Whether the device stops working suddenly or causes unwanted side effects, those issues could make a patient sick or cause other serious issues.
When a device isn’t working well or doesn’t meet the legal requirements, the US Food and Drug Administration can alert consumers to that issue. Recently, the US FDA issued a Class I recall of the Philips HeartStart MRx defibrillator, which could malfunction.
According to the news from Feb. 9, the device may malfunction as a result of gas discharge in the tubing of the device. The tube has micro cracks that allow gases to escape and cause a malfunction. When in Automated External Defibrillation mode, the device could malfunction due to the gases allowing for surges to cross the resistors and damage them.
An AED device like this one needs to work every time. Not working property could lead to someone dying when he or she would have otherwise received the life-saving treatment needed to restart or correct his or her heartbeats.
The news reports that this device can fail at any time during use, and it won’t deliver any shocks if it fails while in AED mode. The device will continue to work in manual mode, but in that mode, it may be hard for rescue workers to interpret the device’s readings due to noisy output.
Not getting treatment because of a defective device could lead to serious injuries or death. Patients who are harmed by this or other devices like it should know that they have a right to pursue compensation.
Source: Cardiology Advisor, “Device Recall: HeartStart MRx Defibrillator Gas Chamber Tube Defect,” Britt Gambino, Feb. 09, 2018