A California photographic equipment company failed to file a required report with the FDA about a modification made to a camera to reduce a health risk in response to a customer complaint, the agency said in a Form 483 report.
The company, Motion Analysis, of Santa Rosa, also lacked adequate procedures for reporting such incidents and for receiving and investigating complaints, the FDA said in the report on its July inspection. Several of the findings had been noted in a 2016 inspection, the report said.
Motion Analysis manufactures cameras and other equipment to capture and measure the movement of humans and objects. The company sells its products for use in sports and physical training, film and video production, industrial design and other areas.
The FDA citations mostly relate to the company’s response to a 2015 complaint from a customer about the malfunctioning of two of the company’s Kestrel cameras. The customer said that after the cameras were set up and the power was turned on for the movement-capture system, one camera “shorted, sparked and began smoking” and a second camera did not turn on, the Form 483 said.
A company investigation determined the cause was a screw in the camera assembly that was too long for its intended function, the report said. Motion Analysis replaced the two malfunctioning cameras and notified its customers who might be affected by the too-long screw.
But the company did not report the removal of the screw to the FDA, as it was required the do, the agency said.