BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1731070 · Received June 15, 2010

    Report

    Report Number
    1720753-2010-01772
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Report Date
    June 14, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE SBC COIN BATTERY. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING A COMMUNICATION ERROR AND THE MONITORS ARE NOT WORKING. 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