FDA Adverse Event Other Summary report: N

FLUOROSCOPE

MDR report key: 631895 · Received June 24, 2005

Report

Report Number
631895
Event Type
Other
Date Received
June 24, 2005
Date of Event
May 4, 2005
Report Date
June 24, 2005
Manufacturer
GE OEC MEDICAL SYSTEMS
Product Code
JAA
Report Source
User Facility report
Reporter Location
IL, US

Narratives

Description of Event or Problem · 1

AFTER APPROXIMATELY 1 SECOND OF FLUORO EXPOSURE, THE IMAGE ON THE SCREEN BLOOMED I.E. THE IMAGE STARTED AS AN ACCEPTABLE IMAGE QUALITY THEN FADED TO WHITE. NO ATONOMY COULD BE SEEN. OID TO PATIENT WAS ADJUSTED, MAGNIFICATION WAS ALTERED, GRID WAS SLID IN AND OUT AND NONE OF THESE RESOLVED THE PROBLEM. IT APPEARS THAT IMAGE RECEPTOR PHOSPHOR OR CAMERA IS SUSPECT SINCE THE IMAGE WASHES OUT I.E. BLOOMS POSSIBLE DUE TO OVER EXPOSURE. FOLLOW UP REVEALS: OUR RADIOLOGY CHARGE PERSON, WAS NOTIFIED OF IMAGE QUALITY ISSUES IN THE GI LAB. THEY RE-ADJUSTED THE CONTRAST ON THE SCREEN. AND THEY FOLLOWED UP A FEW DAYS LATER AND DID NOT FIND ANY FURTHER PROBLEMS. APPROXIMATELY A WEEK LATER, THERE WAS DISCUSSION ABOUT THE IMAGES BEING TOTALLY WHITED OUT AND NON READABLE DURING THE CASE. THE INITIAL IMAGES AT THE BEGINNING OF THE CASE WERE FINE, BUT DURING THE CASE, ALL IMAGE QUALITY WAS LOST. OUR BIOMED DEPARTMENT INVESTIGATED THE PROBLEM THAT AFTERNOON. THEY WERE UNABLE TO FIND THE CAUSE OF THE PROBLEM, THEREFORE, THE MANUFACTURER OF THE EQUIPMENT (GE) CAME IN A FEW DAYS LATER. GE FOUND AN INTERNAL PROBLEM WITH THE CAMERA AND INSTALLED A NEW CAMERA BEAM THE NEXT DAY. THE SITE DID NOT ALLOW THE EQUIPMENT TO BE USED UNTIL THEN. THE SITE HAS NOT HAD ANY FURTHER INSTANCES OF LOST IMAGE QUALITY SINCE THEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLUOROSCOPE FLUOROSCOPY SYSTEM GI LAB JAA GE OEC MEDICAL SYSTEMS * *

Patients

Seq Age Sex Outcome Treatment
1 43 YR