BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 4201339 · Received October 27, 2014

    Report

    Report Number
    1226181-2014-00540
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. THE HSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE IOC COMMUNICATION ERROR WAS DUE TO OVERHEATING OF THE INSTRUMENT'S HEAT TORCH ELEMENT. THE HSC INSTRUCTED THE CUSTOMER TO REPLACE THE HEAT TORCH. THERE WAS NO OTHER DAMAGE OR INJURY CAUSED BY THE OVERHEATED HEAT TORCH ELEMENT. 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 PLUS WITH HM INSTRUMENT DURING THE TIME WHEN THE INSTRUMENT DISPLAYED AN INPUT/OUTPUT COMPARATOR (IOC) COMMUNICATION ERROR. 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
    683163 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1