BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2040362 · Received February 15, 2011

    Report

    Report Number
    1720753-2011-02248
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 15, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED. THE SYS WAS TESTED AND IS NOW OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE C-ARM ON THE 9800 SYS WOULD NOT LIFT. NO PT 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