BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PERINATAL (QUANTITATIVE SENTINEL)

    MDR report key: 1148903 · Received August 29, 2008

    Report

    Report Number
    3004526608-2008-00059
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 7, 2007
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    HGM
    PMA / PMN Number
    K993008
    Removal / Correction Number
    3004526608-8/29/08-009-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALERTS AND REMINDERS FEATURE FOR 6.80.0 WAS ENABLED FOR ONE CUSTOMER. GE HEALTHCARE INTEGRATED IT SOLUTIONS HAS PROVIDED THE AFFECTED CUSTOMER WITH A SOFTWARE CORRECTION FOR BOTH ISSUES. THIS CORRECTION WILL ALSO BE IMPLEMENTED IN ANY NEW RELEASE OF THIS SOFTWARE GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR A SPECIFIC ALERT OR REMINDER FOR A GIVEN PATIENT, AN INCONSISTENT COLOR MAY BE DISPLAYED FOR THE SAME CLINICAL ELEMENT ACROSS A SET OF WORK STATIONS. FOR EXAMPLE, TWO WORK STATIONS POSITIONED SIDE BY SIDE MAY SHOW A CLINICAL ELEMENT IN GREEN IN ONE DISPLAY AND YELLOW IN ANOTHER. THIS CAN RESULT IN A DELAY OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PERINATAL (QUANTITATIVE SENTINEL) CENTRICITY PERINATAL HGM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1