FDA Investigating Faulty Power Cords on Medical DevicesOct 20, 2009 | Parker Waichman LLP
Medical device manufacturers Hospira Inc. and Abbott Nutrition have submitted 122 reports of sparking, charring, and fires from faulty power cords used with their devices to the Food & Drug Administration (FDA). Those reports have prompted the agency to launch an investigation to determine if certain types of power cords used with medical devices may be defective.
The FDA's investigation follows a recall of defective AC power cords manufactured by Electri-Cord Manufacturing Corporation issued by Hospira in August. Items included in this recall include several LifeCare and Plum products, along with the Oximetrix 3 SO2/CO Cardiac Output Computer, Nutrimix Micro Compounder and the GemStar Docking Station. Hospira began working with its customers the week of August 16 to replace all affected power cords regardless of their condition.
According to a notice posted on the FDA Web site, all the reports received so far from Hospira and Abbott have involved AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. The companies' investigations of these reports determined that the power cord's prongs may crack and fail at/or inside the plug.
The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including, death
According to the FDA, Electri-cord has supplied the affected power cords to other medical device manufacturers. The agency is now attempting to determine which devices may be equipped with these cords.
The FDA is advising that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire, the agency said.