BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK ATLAS (SHORT DOOR)

    MDR report key: 3961914 · Received July 28, 2014

    Report

    Report Number
    1217157-2014-00105
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    KQO
    PMA / PMN Number
    K932674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAD A FIELD SERVICE ENGINEER (FSE) GO ON SITE. UPON REVIEW OF INSTRUMENT FOUND DAMAGED PH2 SENSOR ON RACKHANDLER. APPEARS LIQUID HAD DROPPED ON THE PH2 SENSOR AND CAUSED A SHORT. FSE REPLACED PH2 SENSOR, TESTED AND SYSTEM IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SMOKE COMING OUT OF THE FRONT OF THE INSTRUMENT AND SMELLED A BURNING ODOR. CUSTOMER SAFELY DISCONNECTED POWER FROM INSTRUMENT. NO PATIENT SAMPLES WERE BEING RUN AT TIME OF EVENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437953 CLINITEK ATLAS (SHORT DOOR) CT ATLAS KQO SIEMENS HEALTHCARE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1