BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2030526 · Received March 9, 2011

    Report

    Report Number
    1720753-2011-02068
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 9, 2011
    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 ON SITE INVESTIGATION. THE PS3 POWER SUPPLY WAS RESEATED AND ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9800 SYSTEM WOULD NOT CAPTURE IMAGES DURING A CASE. THE SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1