BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION RXL MAX WITH HM

    MDR report key: 3873260 · Received June 13, 2014

    Report

    Report Number
    1226181-2014-00326
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE ANALYZED THE INSTRUMENT AND DETERMINED THAT THE CAUSE OF THE SMOKE WAS DUE TO A MALFUNCTION IN THE INSTRUMENT UNINTERRUPTABLE POWER SUPPLY (UPS). THE CSE REPLACED THE UPS AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    SMOKE EMISSION WAS DETECTED ON A DIMENSION RXL MAX WITH HM INSTRUMENT EXTERNAL UNINTERRUPTABLE POWER SUPPLY (UPS) . THE INSTRUMENT WAS TURNED OFF TO STOP THE SMOKE EMISSION. THERE WERE NO REPORTS OF STAFF INJURY, DAMAGE TO PROPERTY OR IMPACT TO PATIENTS DUE TO THE SMOKE EMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349085 DIMENSION RXL MAX WITH HM CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION RXL MAX WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1