BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 3843442 · Received March 14, 2014

    Report

    Report Number
    1720753-2014-02344
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GE OEC MEDICAL(SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THAT THE KEY SWITCH REQUIRES REPLACEMENT, HOWEVER, NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS NOT AVAILABLE AND THE CUSTOMER CANCELLED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE FE DESCRIBED A SITUATION IN WHICH THE SYSTEM FAILED TO BOOT UP. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154128 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL(SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1