BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1992988 · Received February 8, 2011

    Report

    Report Number
    1720753-2011-01076
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 8, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. A HAND CONTROL WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM DISPLAYED A FOOT SWITCH ERROR AND A SAFETY ERROR. NO REPORT OF PATIENT INJURY.

    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