Editor05.15.09
The U.S. Food and Drug Administration has released a warning letter citing Nidek Medical Products Inc., based in Birmingham, Ala., for failing to properly document complaints about the company’s oxygen concentrators.
The FDA pointed out three problems in the letter:
1. An oxygen concentrator malfunction in which a capacitor started burning while a patient was using the machine
2. An overheated capacitor that caused “significant damage to the Mark 5 Plus Oxygen Concentrator”
3. An oxygen concentrator "burned due to the device being manufactured with an incorrect voltage module"
The FDA also said the company failed to conduct adequate investigations of complaints, including one incident that involved the death of a patient.
A spokesman for the company said the problem involved mostly regulatory paperwork and has been largely resolved.
Nidek Medical Products Inc. manufactures oxygen concentrators. It has warehouses in South America and Europe, as well as a sister company in India.
Visit www.fda.gov/foi/warning_letters/s7180c.htm to view the complete warning letter.
The FDA pointed out three problems in the letter:
1. An oxygen concentrator malfunction in which a capacitor started burning while a patient was using the machine
2. An overheated capacitor that caused “significant damage to the Mark 5 Plus Oxygen Concentrator”
3. An oxygen concentrator "burned due to the device being manufactured with an incorrect voltage module"
The FDA also said the company failed to conduct adequate investigations of complaints, including one incident that involved the death of a patient.
A spokesman for the company said the problem involved mostly regulatory paperwork and has been largely resolved.
Nidek Medical Products Inc. manufactures oxygen concentrators. It has warehouses in South America and Europe, as well as a sister company in India.
Visit www.fda.gov/foi/warning_letters/s7180c.htm to view the complete warning letter.