BN II SYSTEM

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE DUE TO WASTE TANK FULL ERRORS AND THE WASTE PUMP NOT ACTIVATING. UPON MANUALLY ACTIVATING OF THE WASTE PUMP VIA SERVICE SOFTWARE BY THE CSE, A FLASH WITH SMOKE WAS VISIBLE. AFTER OBSERVING THE SMOKE AND FLASH, THE CSE REMOVED THE WASTE PUMP AND VOLTAGE REGULATOR FROM THE SYSTEM. THE CSE CONFIRMED THE CORRECT FUNCTIONING OF ALL OTHER SUBSYSTEMS ON THE SYSTEM. QUALITY CONTROLS (QC) WERE THEN RUN AND RECOVERED ACCEPTABLY. A NEW VOLTAGE REGULATOR AND WASTE PUMP HAVE BEEN ORDERED FOR THE CUSTOMER. THE CUSTOMER IS CURRENTLY ABLE TO USE THE SYSTEM, BUT THEY ARE REQUIRED TO MANUALLY EMPTY THE WASTE TANK. SIEMENS IS INVESTIGATING THE ISSUE. THE BN II SYSTEM IS MARKETED IN THE UNITED STATES UNDER MATERIAL NUMBER 11254820. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

Description of Event or Problem

UPON MANUALLY ACTIVATING THE CUSTOMER'S BN II SYSTEM'S WASTE PUMP VIA SERVICE SOFTWARE, THE VOLTAGE REGULATOR BURNED OUT AND GENERATED A FLASH WITH VISIBLE SMOKE. 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.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2024-00001 ON 18-JAN-2024. ADDITIONAL INFORMATION (30-JAN-2024): THE REPORTED PROBLEM WAS RESOLVED BY REPLACING THE VOLTAGE REGULATOR AS WELL AS THE WASTE PUMP AND THE DISTR_MV BOARD. THE SYSTEM IS OPERATIONAL. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION.