A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ONCOR IMPRESSION PLUS LINEAR ACCELERATOR WITH THE 550 TXT TABLE. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. A DEFECTIVE 24V POWER SUPPLY CAUSED IN THE 550 TXT TABLE SMOULDERING FIRE OF THE COMPONENTS MOUNTED ABOVE IT: RELAYS K1, K2, K101 AND THE CABLE HARNESS. THE CUSTOMER IS EXTREMELY WORRIED BECAUSE OF THE STRONG SMOKE EMISSION. THE INNER PARTS OF THE TABLE WERE COMPLETELY POLLUTED BY SOOTY PARTICLES OF THE BURNED CABLE INSULATION. ROOT CAUSE IS PENDING INVESTIGATION. CORRECTIVE ACTION IS PENDING INVESTIGATION. RISK ASSESSEMENT IS COMPLETED. NO INJURY OR MISTREATMENT HAS BEEN REPORTED.
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Patient 1
SEVERITY: 3 (CRITICAL). REASON: IF THE POTENTIAL FOR FIRE IS NOT MITIGATED, IT COULD RESULT IN SERIOUS INJURY OR DEATH. PHYSICIAN CARE REQUIRED TO TREAT FOR SMOKE INHALATION. PROBABILITY: PRELIMINARY C (REMOTE) REASON: SMOULDERING FIRE OCCURED FOR 2 OUT OF ABOUT 430 INSTALLED TABLES OF TYPE 550 TXT. IN BOTH CASES THERE WAS NO INJURY REPORTED. FIRE RETARDANT COMPONENTS WIL PREVENT CATASTROPHIC FIRE ONCE POWER IS REMOVED FROM MAIN SOURCE. MOST OF THE COMPONENTS ARE ALSO SURROUNDED BY METAL. IT IS ALSO REASONABLE TO EXPECT THAT THE BURNING SMELL WILL ALERT THE USER IMMEDIATELY AND SHOULD PROVIDE AMPLE TIME TO REMOVE POWER FROM SYSTEM AND REMOVE PATIENTS FROM THE TREATMENT AREA TO PREVENT SMOKE INHALATION OR SERIOUS INJURY. SEVERAL INTERLOCKS ARE IN PLACE WHICH WOULD POWER OFF THE SYSTEM IN CASE OF SHORT CIRCUITS CAUSED BY DEFECTIVE PRINTED CIRCUIT BOARDS. THE TXT TREATMENT TABLE MENTIONED AND ABOVE IS IDENTIFIED AS FOLLOWS: MATERIAL NUMBER 7346534, (B) (4).