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Company denies producing defective medical device

It may be difficult for some people in California to imagine a world without any medical errors whatsoever. However, the founder of the organization Patient Safety Movement Foundation set out to do just that. The founder of the nonprofit also happens to be the CEO of a prominent medical device company. Despite the talks of improvement, the FDA has noted that his company, Masimo Corporation, may not be doing everything it can to avoid marketing an unnecessary defective medical device.

Although none of the products have actually been deemed defective yet, there have been various complaints about Masimo products. One such claim stated that a patient suffered toe burns. Another complaint called into question an alarm that may have failed to go off shortly before a patient ended up dying.

After the myriad of complaints, the FDA reprimanded Masimo with an official warning letter. In the letter, the FDA noted that Masimo had not responded to complaints about its devices as the company should have. This included failing to disclose some of these complaints to the FDA. 

Masimo has also allegedly questioned the validity of the complaints and completely denied that any of its products were defective. However, California patients who have been injured due to defective devices may feel as though they have no options, particularly when large companies deny that they produced a defective medical device. Compensation for these victims can be critical to recovery, as it can cover lost wages and help cover costly medical or rehabilitation bills. For many victims, the successful litigation of a medical malpractice claim can be one of the first small steps toward recovery.

Source: kuow.org, "Medical Company May Be Falling Short Of Its Patient Safety Ideals", Marshall Allen, Oct. 6, 2014

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