BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1882977 · Received October 15, 2010

    Report

    Report Number
    9680959-2010-00408
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    May 25, 2010
    Report Date
    October 15, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE IMAGE PROCESSOR WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1