BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1860046 · Received September 17, 2010

    Report

    Report Number
    1720753-2010-03123
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 17, 2010
    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 REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE KV CONTROL PCB AND KV CONTROL RIBBON CABLE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR FAILURE ERROR MESSAGE DURING A CASE. NO PATIENT 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