BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDPOINT 405

    MDR report key: 2509435 · Received March 26, 2012

    Report

    Report Number
    1217157-2012-00011
    Event Type
    Other
    Date Received
    March 26, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF CUSTOMERS PRESS "PT LIST" ON THE DEMOGRAPHICS SCREEN THE SYS WILL PRE SELECT THE PREVIOUS PT. THEY CAN EITHER PRESS THE "BACK" BUTTON WHICH WILL IGNORE THIS AND GO BACK TO THE ORIGINAL SCREEN OR THEY CAN PRESS THE GREEN "CONTINUE" BUTTON WHICH WILL THEN OVERWRITE THE ORIGINAL DATA WITH THE PREVIOUS PT DATA. THE USER MAY PRESS THE "CONTINUE" BUTTON AND INADVERTENTLY OVERWRITE THE DATA BY MISTAKE. THIS "PT LIST" BUTTON CAN BE DISABLE IN SETUP WHICH STOPS THIS FROM HAPPENING AND REMOVES THE OPTION FROM THE DEMOGRAPHICS SCREEN. SYS IS FUNCTIONING AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A PROBLEM WITH THE RAPIDCOMM SOFTWARE FOR THE RP405 SYS. CUSTOMER HAD "SAVE DEMOGRAPHICS" TURNED ON FOR A PT SAMPLE BEING RUN ON THE SYS AND CLAIMS THE SYS GAVE THE WRONG PT DEMOGRAPHICS. NO INJURY WAS REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT 405 RAPIDPOINT 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. 405

    Patients

    Seq Age Sex Outcome Treatment
    1