Although he says his cords are often fashioned to meet the rigors of hospital and even military uses, "You can only go so far with PVC, plastic and metal."

What You Should Do


If a medical device that uses a power cord with a black plastic bridge has bent or cracked prongs, an outer sheath that is visibly burnt, black residue, or signs of excessive wear and tear, the FDA recommends the following actions:

--A contingency plan to prevent any disruption of patient care.
--Refrain from using the device with the affected power cord as soon as possible, without jeopardizing patient care.
--Contact the medical device manufacturer or sales representative to report the power cord failure and request appropriate replacement or repair.
--Submit a report to the Food and Drug Administration in the "Reporting Problems" section (accessible from the Initial Communication page).

The FDA says personnel in health care facilities should follow protocols for handling equipment malfunctions as required by their respective facilities.

If a device manufacturer has products that have a power cord manufactured by Electri-Cord, or if a manufacturer has received complaints of device malfunction associated with sparking, charring, or fires from the power cords, the manufacturer should:

--Evaluate the medical device to determine whether the power cord is the source of any problems associated with sparking, charring or fires.
--Report events to FDA on FDA Form 3500A, for any complaints that meet the requirements stated in 21 CFR, Part 803 "Medical Device Reporting."
--Perform appropriate voluntary correction and/or removal action as stated in the requirements under 21 CFR, Part 806, "Reports of Corrections and Removals."

Read more:

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

FDA Initial Communication: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm
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Astrid Fiano contributed to this report

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