FDA Warns About Defective Power Cords
FDA Warns About Defective Power Cords
October 19, 2009 — The US Food and Drug Administration (FDA) is investigating certain power cords used with medical devices to determine whether they are defective, the agency announced today.
Hospira Inc and Abbott Nutrition have reported 122 cases of sparking, charring, and fires from power cords used with their devices. The incidents may have been caused by the power cord's prongs cracking or failing.
"The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death."
All 122 cases have involved power cords with a black plastic bridge and were manufactured by Electri-cord Manufacturing Company. The company has supplied these types of power cords to other device manufacturers, and the FDA is in the process of determining which devices have the affected cords.
Healthcare providers and users of devices with these power cords should closely monitor the "wear and tear" on the cords. Such monitoring is particularly important in oxygen-rich settings, where electrical sparking and related incidents are likely to start a fire, according to the FDA.
More information is available on the FDA's initial communication about this issue on the FDA's Web site.
Any serious adverse events potentially related to use of medical device power cords may be reported to the company by telephone at 1-800-734-9236, Monday through Friday, from 9:00 AM to 5:00 PM eastern time. Adverse events may also be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
October 19, 2009 — The US Food and Drug Administration (FDA) is investigating certain power cords used with medical devices to determine whether they are defective, the agency announced today.
Hospira Inc and Abbott Nutrition have reported 122 cases of sparking, charring, and fires from power cords used with their devices. The incidents may have been caused by the power cord's prongs cracking or failing.
"The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death."
All 122 cases have involved power cords with a black plastic bridge and were manufactured by Electri-cord Manufacturing Company. The company has supplied these types of power cords to other device manufacturers, and the FDA is in the process of determining which devices have the affected cords.
Healthcare providers and users of devices with these power cords should closely monitor the "wear and tear" on the cords. Such monitoring is particularly important in oxygen-rich settings, where electrical sparking and related incidents are likely to start a fire, according to the FDA.
More information is available on the FDA's initial communication about this issue on the FDA's Web site.
Any serious adverse events potentially related to use of medical device power cords may be reported to the company by telephone at 1-800-734-9236, Monday through Friday, from 9:00 AM to 5:00 PM eastern time. Adverse events may also be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Source...