BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND WITH HM

    MDR report key: 3760158 · Received April 18, 2014

    Report

    Report Number
    1226181-2014-00213
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT AND INSTRUMENT DATA EVALUATION. AFTER EVALUATION, THE CSE DETERMINED THAT THE INSTRUMENT DISPLAYED A PHOTOMETER ERROR DURING THE TIME OF THE EVENT. THE CSE REPLACED THE PHOTOMETER PRINTED CIRCUIT BOARD AND SOURCE LAMP. THE CSE ALSO CLEANED THE PHOTOMETER LENSE AND SUCCESSFULLY VERIFIED SYSTEM OPERATION. THE CAUSE OF THE SMOKE WAS DUE TO A COMPONENT FAILURE ON THE PHOTOMETER PRINTED CIRCUIT BOARD. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SMOKE BEING EMITTED FROM A DIMENSION XPAND WITH HM INSTRUMENT. THE CUSTOMER TURNED THE INSTRUMENT OFF. THERE WAS NO HARM OR INJURY TO THE OPERATOR OR LABORATORY PERSONNEL DUE TO SMOKE COMING FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236993 DIMENSION XPAND WITH HM CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1