BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2041057 · Received March 23, 2011

    Report

    Report Number
    1720753-2011-02335
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    April 28, 2010
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE HARD DISK DRIVE WAS REPLACED. THE CABLE FROM THE HARD DISK DRIVE TO THE GPOS WAS REPLACED. THE SYSTEM SOFTWARE AND CALIBRATION FILES WERE RE-LOADED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT CORRUPTED SAVED IMAGES ON THE 9900 SYSTEM. NO PT 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