BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3093383 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05390
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. HOWEVER, THE CAMERA CONNECTOR CONTACTS WERE CLEANED ON BOTH THE C-ARM AND WORKSTATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181743 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1