BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2023050 · Received February 24, 2011

    Report

    Report Number
    9680959-2011-00557
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DISK WAS REPLACED, AND THE SOFTWARE WAS RECONFIGURED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7900 SYSTEM WILL INTERMITTENTLY FAIL TO BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1