BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1000006 · Received February 20, 2008

    Report

    Report Number
    9680959-2008-00025
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. ORDERED AND DELIVERED A REPLACEMENT IMAGE INTENSIFIER (II) POWER SUPPLY TO CUSTOMER. IT IS BELIEVED THAT THIS COMPONENT WILL ADDRESS THE REPORTED ISSUE. NO ADDITIONAL INFO AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED THAT INDICATES, OTHERWISE AN ADDITIONAL REPORT WILL BE FILED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE INTENSIFIER (II) POWER SUPPLY ON THE 7700 SYSTEM FAILED. REQUEST MADE FOR A NEW II POWER SUPPLY. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1