BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3042329 · Received April 4, 2013

    Report

    Report Number
    1720753-2013-04621
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138291 2800 FLUOROSCOPIC-X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1