BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2922810 · Received January 18, 2013

    Report

    Report Number
    2432235-2013-00029
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED THE CUSTOMER SITE. THE FSE TESTED THE FACILITY ELECTRICAL CONNECTIONS THEN REPLACED THE POWERVAR UNINTERRUPTED POWER SOURCE (UPS). THE FSE MONITORED THE FUNCTIONALITY OF THE NEW UPS THEN MADE ALL APPROPRIATE INSTRUMENT CONNECTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE POWERVAR UNINTERRUPTED POWER SOURCE ( UPS) CONNECTED TO THE ADVIA 1800 SYSTEM BEGAN TO EMIT SMOKE, CAUGHT FIRE AND THE BATTERY SUBSEQUENTLY FAILED. THE USER RECEIVED A VERY SLIGHT 1ST DEGREE BURN WITH SINGED HAIR ON HIS HAND. NO MEDICAL TREATMENT WAS NECESSARY. THERE ARE NO REPORTS OF ANY DAMAGE TO ANY LABORATORY OR SURROUNDING EQUIPMENT. THE UPS WAS DISCONNECTED FROM THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27531 ADVIA 1800 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1