BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PERINATAL (QUANTITATIVE SENTINEL)

    MDR report key: 1156228 · Received September 4, 2008

    Report

    Report Number
    3004526608-2008-00079
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    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
    NURSE

    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

    NURSE REPORTED THAT THE ALERTS AND REMINDERS ICON WAS GRAY, INDICATING UNASSIGNED ALERTS AND REMINDERS WHEN REMINDERS WERE ASSIGNED. THERE WAS NO REPORT OF ADVERSE PATIENT OUTCOME ASSOCIATED WITH THIS EVENT.

    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