BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1864989 · Received October 6, 2010

    Report

    Report Number
    9680959-2010-00369
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED NOR IDENTIFIED. HOWEVER, IT WAS FOUND TO HAVE NO AUDIO BOOT UP. THEREFORE, THE BUZZER WAS REPLACED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS SHUTDOWN AND FAILED TO RESTORE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPY X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1