BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1852197 · Received September 29, 2010

    Report

    Report Number
    1720753-2010-03294
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THAT THE SYSTEM WAS RUNNING SLOW. HARD DRIVE APPEARED TO BE FAILING. OPERATING ROOM TECH WAS ABLE TO DOWNLOAD ALL PERTINENT IMAGES TO PACS BEFORE REPLACING HARD DRIVE. REPLACED HARD DRIVE. TESTED AND VERIFIED PROPER OPERATION OF THE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY WERE UNABLE TO RECALL IMAGES. 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