BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 19799069 · Received July 22, 2024

    Report

    Report Number
    2432235-2024-00157
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 22, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT SMOKE OR STEAM EMITTED FROM THE LAMP COOLANT RESERVOIR WHEN AN OPERATOR ADDED LAMP COOLANT TO THE RESERVOIR ON THE ATELLICA CH 930 ANALYZER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE CSE INSPECTED THE INSTRUMENT, REPLACED THE LAMP COOLING RESERVOIR/PUMP ASSEMBLY, LAMP COOLING RADIATOR FAN ASSEMBLY, AND RAN AN AUTO CHECK, WHICH RECOVERED ACCEPTABLY. THE CSE ALSO DETERMINED THAT FLUID WAS PUMPING PROPERLY THROUGH THE ANALYZER. THE CAUSE OF THE EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AS PART OF WEEKLY MAINTENANCE, AN OPERATOR CHECKED THE LAMP COOLANT LEVEL; SUBSEQUENTLY, THE OPERATOR ADDED ADDITIONAL LAMP COOLANT TO THE LAMP COOLANT RESERVOIR OF THE ATELLICA CH 930 ANALYZER. WHILE DOING SO, THE OPERATOR OBSERVED THAT SMOKE OR STEAM EMITTED FROM THE RESERVOIR. NEXT, THE OPERATOR REMOVED A SMALL VOLUME OF COOLANT FROM THE INSTRUMENT AND DETERMINED THAT THE COOLANT WAS AMBER. THERE ARE NO KNOWN REPORTS OF VISIBLE FLAMES, BURNING SMELL OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936488 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown