FDA announced that an investigation has been launched into problems with certain types of medical device power cords, 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. FDA says 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 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.
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.
October 22nd, 2009 at 3:24 pm
Power cords often have the least amount of engineering and quality time allotted to them in an entire project. Shipping boxes get more attention! Cost is usually the only factor considered (aside from the alphabet soup of letters representing certifications of some sample, somewhere, is said to have received) and in this case, to the peril of end users and patients alike!
October 22nd, 2009 at 6:21 pm
Power cords and connectors should follow the same medical device design controls, feasibility testing and validations required for the device itself. I bet if you went back and looked at the DHF, you’d find very little attention to the cord and plug. It’s a shame, but the efficacy of a medical device should be determined by the entire system, tip to tail. You don’t put 100 dollar tires on a Ferrari.
October 22nd, 2009 at 7:14 pm
The greates product in the world will be labeled a piece of crap the second it does not power on. The pathetic piece of rubber and string with some wire woven in that passes as a power cord on some devices should be an embarassment to some companies. There are many successful, time proven designs that can be incorporated into quality products. This does not require FDA regulation, merely quality supplier selection.
October 22nd, 2009 at 11:16 pm
Medical device manufacturers assume (wrongly) that cable vendors take care of fatigue testing for cable assemblies. Its is the responsibility of the device manufacturer (who is the final product assembly user) to perform fatigue and normal use testing on ALL aspects of their device before going to market. A [good] manufacturer will know the failure mode of every part of his device. If this was done, the problem would most likely have been caught before the product went out to end users.
October 23rd, 2009 at 11:53 am
We have not found it to be the case that they get the least amount of scrutiny. The UL standards are rigorous and if tested properly should provide for a safe to use component. If Eletri-Cord has not changed their processes or raw materials, than the fault lies on the agency that conducted the testing.
We have found however, that UL standards can be interpreted in as many different ways as there are testers. We test our products in house to the standard prior to taking it to UL or TUV for testing to make sure we are comfortable with the result.