BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2040385 · Received February 15, 2011

    Report

    Report Number
    1720753-2011-02242
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 15, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE ORDERED A NEW SURGE SUPPRESSOR BOARD FOR THE CUSTOMER TO INSTALL. THE CUSTOMER INSTALLED THE BOARD AND CONFIRMED THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2800 SYSTEM NEEDED A NEW SURGE SUPPRESSOR BOARD THAT NEEDED TO BE ORDERED BY A FIELD SERVICE ENGINEER. NO SPECIFIC SYSTEM FAILURE WAS REPORTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1