BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 2853413 · Received November 30, 2012

    Report

    Report Number
    1226181-2012-00137
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 4, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS TECHNICAL SUPPORT CENTER (TSC) CONTACTED THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THE OPERATORS WERE NOT INJURED BY THE INCIDENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A BIO-WASTE TUBE OF A DIMENSION VISTA 500 INSTRUMENT SPLASHED INTO THE FACES OF TWO OPERATORS. THE OPERATORS WASHED THEIR FACES. BLOOD SAMPLES WERE DRAWN FOR (B)(6) TESTS. THERE ARE NO KNOWN REPORTS OF INJURY OR ADVERSE HEALTH CONSEQUENCES FOR THE OPERATORS DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1