BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4912109 · Received July 10, 2015

    Report

    Report Number
    1720753-2015-02785
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 29, 2015
    Report Date
    July 10, 2015
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM SOFTWARE AND CONFIGURATION FILES WERE EVALUATED AND RELOADED. THE CABLE AND FUSE FH23 IN THE WORKSTATION WERE ALSO REPLACED DURING THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448597 9900 JAA 9900 E2-2960

    Patients

    Seq Age Sex Outcome Treatment
    1