BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2041411 · Received March 23, 2011

    Report

    Report Number
    1720753-2011-02655
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE AUTOMATIC EXPOSURE CHAMBER WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE INSPECTOR REPORTED AN AUTOMATIC EXPOSURE CHAMBER - LEFT CELL, ERROR. 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