MAMMOGRAPHY FILM PROCESSOR
Received May 24, 1996
Report MW4001374 · MDR key 33819
Device
Product problems
- False Device Output
- Film processing, inadequate
- Product Quality Problem
- Inadequate Service
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
UNABLE TO PROCESS MAMMOGRAPHY X-RAY FILMS DUE TO POOR DESIGN. THE PROCESSOR IN QUESTION WAS INSTALLED IN 6/94, SINCE THEN NUMEROUS PROBLEMS HAVE OCCURRED. A DISTINCT FLAME PATTERN ON FILM WAS FROM A POOR DESIGN IN THE DEVELOPER RECIRCULATION SYSTEM. ROLLER MARKS WERE BEING LEFT ON FILMS FROM POORLY DESIGNED DEVELOPER ROLERS AND CROSSOVER RACKS WHICH MADE RADIOGRAPHS UNACCEPTABLE BY ACR. DEFECTIVE TEMP CONTROL MICROPROCESSOR BOARD RENDERED THE PROCESSOR UNABLE TO PROCESS MAMMOGRAPHY FILMS. THE LAST PROBLEM THAT WAS ENCOUNTERED WAS AN ICICLE PATTERN ON THE FILM THAT COULD NOT CORRECT, AND WAS CAUSED BY THE FAULTY RACK SYSTEM. SINCE THIS UNIT WAS INSTALLED IN 6/94 THIS UNIT HAS YET TO PROCESS AN ACCEPTABLE X-RAY FILM. CO SVC AND REPAIR PERSONNEL HAVE MADE NUMEROUS ATTEMPTS TO REPAIR THIS UNIT WITHOUT SUCCESS.