FDA Investigating Medical Device Power Cord Problems

The FDA announced Monday that an investigation has been launched into problems with certain types of medical device power cords, including those used with devices manufactured by Hospira, Inc. and Abbott Nutrition, after a number of reports that the cords are sparking, causing fires and potentially resulting in device failure.

At least 122 reports of medical device cord malfunctions have been received by the agency, which issued an initial communication to patients and healthcare professions about the problems. The FDA indicates that the plugs have the potential to cause electric shock, interruption of therapy, device failure and fires, which could lead to serious injury or death.

The reports all involve Hospira or Abbott devices that have AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. The cords are used with a number of medical manufacturers, and the FDA is in the process of determining which specific medical devices may be affected.

Investigations so far suggest that the problems are caused by the prongs of the power cords cracking and failing at, or inside, the plug.

The FDA warns that all users of medical devices should be aware of the wear and tear on power cords. The agency recommends that any users who find they have cords with the black plastic bridge between the prongs should look closely for bent or cracked prongs, visible burns on the outer sheath, black residue or excessive signs of use and damage.

If you have one of the affected cords, and it is showing signs of damage, the FDA recommends the following:

• Have a contingency plan to prevent any disruption of patient care.
• Stop using the device with the affected power cord as soon as possible.
• Contact the medical device manufacturer or sales representative to report the power cord failure and to request the appropriate replacement or repair.
• Submit a report to the FDA’s MedWatch program.

For information about cord replacement, consumers can contact Hospira at (800) 615-0187 or Abbott Nutrition at (877) 457-0249.