BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3170735 · Received June 14, 2013

    Report

    Report Number
    1226181-2013-00265
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE FSE DISCOVERED THAT THE SMOKE HAD ORIGINATED FROM THE POWER SUPPLY. THE FSE REPLACED THE POWER SUPPLY AND THEN VERIFIED THE INSTRUMENT FUNCTIONALITY. THE CAUSE OF THE SMOKE COMING FROM THE INSTRUMENT WAS A MALFUNCTION OF THE POWER SUPPLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF A DIMENSION RXL MAX WITH HM INSTRUMENT SAW SMOKE COMING FROM THE INSTRUMENT. THE OPERATOR SHUT OFF THE POWER TO THE INSTRUMENT AND UNPLUGGED THE POWER CORD FROM THE OUTLET. NO LABORATORY PERSONNEL OR PATIENT SAMPLES WERE IMPACTED BY THE SMOKE COMING FROM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271105 DIMENSION RXL MAX WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1