BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3060337 · Received April 11, 2013

    Report

    Report Number
    1720753-2013-04875
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THIS RECORD CONCERNS COMPLAINTS OF LOW MA AND KV ERROR MESSAGES AND A SHUT DOWN WHEN OPERATING IN RARE TECHNIQUES. PER THE FE, THE CUSTOMER MISUNDERSTOOD THESE ERROR MESSAGES FOR HEAT WARNINGS AND THEREFORE REPORTED IT AS OVERHEATING AND SHUTTING DOWN. HOWEVER, THIS PARTICULAR C-ARM SHUT DOWN WHEN IT WAS OPERATED ONLY IN RARE TECHNIQUES AND ONLY SHUT DOWN FOR THE FE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT OVERHEATED AND SHUT DOWN DURING FLUORO. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156698 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1