Ref.Id: (b)(4).The digital diagnost c90 is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.The local field service engineer (fse) went on site and inspected the skyplate detector.He successfully completed gain and pixel calibrations.He tested the image and returned the system back to the customer with full functionality.Finally, the system meets the specification for the performed service and is returned to use.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).Risk estimation revealed acceptable risk per risk benefit analysis, because actually, there is no feasible technical solution for this kind of ¿use error¿.This issue is further monitored and trended.
|