BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3874716 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03597
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CABLE SOCKET WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE CABLE SOCKET (INTERCONNECT CABLE) ON C-ARM HAD MECHANICAL DAMAGE, CABLE COULD NOT BE CONNECTED. THIS MAY RENDER THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248585 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1