Biodex Medical Fails to Establish Quality Control Procedures

Surgical instrument maker Biodex failed to report a medical device failure that resulted in a patient falling to the ground while being transported in an MRI stretcher that malfunctioned, according to a 483 issued following an April 24 to May 1 FDA inspection of the firm’s Shirley, New York, facility.

Biodex received the complaint on Feb. 29, 2016, but did not report the incident to the FDA until May 25 of that year, beyond the required 30-day reporting window for MDR filing.

FDA inspectors said the firm had not established records that described quality control procedures to monitor aluminum equivalence attenuation within its surgical C-Arm tables.