EUREKA COLLIMATOR
Received Jan 22, 2010 · Event occurred Dec 29, 2009
Report 1423380-2009-00031 · MDR key 1593429
Device
Product problems
- Thermal Decomposition of Device
- Fire
- Melted
- Device Remains Activated
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION OF THE UNIT REVEALED THAT THE TRIAC HAD FAILED. THE CERAMIC INSULATOR, WHICH IS USED TO REMOVE THE HEAT FROM THE TRIAC AND ELECTRICALLY ISOLATE THE UNIT FROM GROUND, WAS BROKEN, ISOLATING THE TRIAC FROM THE CHASSIS. THIS CAUSED THE TRIAC TO OVERHEAT AND FAIL IN A SHORTED MODE. THE TRIAC WAS REPLACED AND THE UNIT OPERATED NORMALLY. IN ADDITION, A COLLIMATOR (B) (4) WAS TESTED TO SIMULATE THE FAILURE MODE. THE CUSTOMER COMPLAINT ALLEGING "FIRE" ASSOCIATED WITH A SHORTED OUT LAMP CIRCUIT COULD NOT BE DUPLICATED.
Description of Event or Problem
A DEALER SERVICE ENGINEER CALLED PROGENY ON (B) (6) 2009 REGARDING A COLLIMATOR, (B) (4), WHOSE LAMP CIRCUIT FAILED IN THE "ON" CONDITION CAUSING THE COVER TO BEGIN TO MELT. THE CUSTOMER ALLEGED THAT THE COLLIMATOR INTERNAL WIRING INSULATION CAUGHT FIRE AND CONTINUED TO BURN UNTIL THE WIRING CONNECTION FAILED WHICH STOPPED THE ELECTRIC CURRENT AND BURNING CEASED. NO INJURIES WERE REPORTED. THE UNIT WAS REPAIRED BY PROGENY TECHNICIAN ON 12/28/2009.