BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2100724 · Received May 12, 2011

    Report

    Report Number
    1720753-2011-07242
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ORDERED A NEW LEG EXTENDER. THE CUSTOMER INSTALLED THE NEW PART AND REPORTED THAT THE SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEG EXTENSIONS WERE DIFFICULT TO PUT ON AND GET OFF THE SYSTEM. THIS EVENT OCCURRED INSIDE A PROCEDURE. 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