BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 9900

    MDR report key: 1791419 · Received August 6, 2010

    Report

    Report Number
    1720753-2010-02357
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    May 13, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPAIRED THE PROBLEM; NO GE SERVICE CALL WAS MADE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTION ERROR WAS DISPLAYED WHEN MOVING THE C-ARM OUT OF THE WAY AT THE END OF A PACEMAKER CASE. THIS MESSAGE CONTINUOUSLY POPS UP NOW WHEN THE C-ARM IS BEING USED. WHETHER BEING MOVED OR NOT, THE CUSTOMER PRESSES OK AND THE MESSAGE SOMETIMES DISAPPEARS AND OTHER TIMES IT RETURNS. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1