BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2935234 · Received January 28, 2013

    Report

    Report Number
    1720753-2013-01125
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER-THE-PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED TO LEAVE THE SYSTEM ON SO THAT IT COULD BE ALLOWED TO REPAIR THE SYSTEM FILES. ONCE THAT WAS DONE, THE SYSTEM OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37801 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1