FDA MedWatch - Medical Device Power Cords Safety Investigation: Initial Communication

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Medical Device Power Cords Safety Investigation: Initial Communication

Audience: Healthcare professionals, patients/caregivers

[Posted 10/19/2009] FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. 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.

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. FDA is aware that 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.

FDA recommends 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.

Read the MedWatch safety summary, including a link to the FDA Initial Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420