BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PERINATAL (QUANTITATIVE SENTINEL)

    MDR report key: 1148900 · Received August 29, 2008

    Report

    Report Number
    3004526608-2008-00057
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 12, 2007
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    LLZ
    PMA / PMN Number
    K993008
    Removal / Correction Number
    3004526608-8/29/08-009-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    DURING INTERNAL TESTING CONDUCTED BY GE HEALTHCARE IT ENGINEERING, IT WAS DETERMINED THAT WHEN ATTEMPTING TO SELECT THE LAST VISIBLE ALERT OR REMINDER CHOICE IN THE AVAILABLE SETS WINDOW OF THE ASSIGN ALERT REMINDER SET DIALOG BOX, THE NEXT CHOICE IS ACTUALLY SELECTED. IF THE CAREGIVER DOES NOT NOTICE THAT THE WRONG ALERT OR REMINDER IS SELECTED, THE CAREGIVER WOULD NOT BE ALERTED TO THE PARAMETER THAT SHE/HE IS EXPECTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1