BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1992764 · Received February 4, 2011

    Report

    Report Number
    1720753-2011-00913
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE. THE CUSTOMER STATED THAT THE PERSON USING THE C-ARM AT THE TIME OF THE ERROR WAS NOT FAMILIAR WITH THE SYSTEM AND THE ERROR WAS CAUSED FROM NOT SHUTTING DOWN THE SYSTEM CORRECTLY. THE CUSTOMER STATED THE SYSTEM WAS WORKING FINE AND CANCELLED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL TAKE ONE IMAGE, BUT WILL DISPLAY A COMMUNICATION ERROR ON THE NEXT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1