BCS XP SYSTEM

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE OBSERVATION OF A BCS XP SYSTEM (SN# (B)(6) ) WHICH WAS NOT IN COMMUNICATION WITH THE CENTRAL PROCESSING UNIT (CPU). A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. DURING TROUBLESHOOTING, A CIRCUIT BOARD BLEW A FUSE AND SMOKE WAS VISIBLE. AFTER OBSERVING THE SMOKE, THE CSE REPLACED THE PRINTED CIRCUIT ASSEMBLY (PCA). IT WAS FOUND THAT SMN 11241849 PCA FLASH V4 (LAMP DRIVER BOARD) FAILED, WHICH IS A HIGH VOLTAGE ELECTRONIC BOARD. THE FAILURE OF THE PCA FLASH V4 POSSIBLY CAUSED THE CASCADE OF FAILURES SUCH AS THE BLOWN FUSES, FAILURE OF THE PCA MPOS AND LAMP. THESE PARTS ARE CONTAINED WITHIN THE INSTRUMENT AND NOT ACCESSIBLE TO THE CUSTOMER. PARTS WERE REPLACED AND THE SYSTEM WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE SERVICE PART REPLACEMENT. THE BCS XP SYSTEM IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A BCS XP SYSTEM (SN#(B)(6)) WHICH WAS NOT IN COMMUNICATION WITH THE CENTRAL PROCESSING UNIT (CPU). DURING TROUBLESHOOTING BY THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE), THE SAMPLE TRANSFER PRINTED CIRCUIT BOARD (PCB) BEGAN TO SMOKE BEFORE BLOWING A FUSE. THE CSE FOUND 4 FUSES WERE BLOWN. NO HARM TO THE USER WAS ALLEGED DUE TO THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED DUE TO THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.