FDA puts burning questions to Fukuda Denshi about device

A Japanese maker of electrocardiogram monitoring equipment and software has been raked over the coals by the FDA for not promptly reporting incidents in which patients' lives were in jeopardy. 

In its warning letter to Fukuda Denshi, dated Feb. 21 and posted this week, the FDA cited an incident in which one of the company's devices "was a factor in the death of the patient as a result of user error." In another incident that was not quickly relayed to the agency, one of the devices malfunctioned and burned. The FDA points out that in an environment filled with oxygen equipment, an igniting device poses significant dangers.

In a safety alert posted by the FDA in October, it said there are 550 to 650 surgical fires reported a year, some resulting in second and third-degree burns and occasionally death. Most are in oxygen-enriched environments and medical devices can be the ignition source.

Fukuda also needs to beef up its procedures for investigating as well as reporting adverse reaction incidents, the FDA says, citing a number of medical device reporting failures.

The company did not respond to a request from FiercePharmaManufacturing for comment. 

- read the FDA warning letter
- here's the FDA safety alert