BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1880016 · Received October 13, 2010

    Report

    Report Number
    1720753-2010-03541
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE AND WAS INFORMED THAT THE SYSTEM WAS WORKING FINE. CONTACTED CUSTOMER AGAIN ON (B)(6)2010 AND WAS INFORMED SYSTEM STILL OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED A HIGH CAPACITY DISK ERROR, LOCKED UP, AND STARTED BEEPING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1