의료기기2등급1 Flexible Endoscopes FMEA Flexible Endoscopes No.1 Reported Issue : Flickering/distorted Image Common Cause : Camera / CCD assembly damaged due to corrosion from fluid invasion Effects : Delayed / cancelled procedure while alternative scope is made available potential increase in anesthesia time for patient Repair : Repair or replace camera Resolution : Educate staff on proper leak testing procedures and document in stan.. 2016. 10. 4. 이전 1 다음