BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3182425 · Received June 14, 2013

    Report

    Report Number
    9680959-2013-01165
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A BLOWN FUSE, AND UPGRADED THE WORKSTATION AND POWER CORD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271283 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1