BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2021933 · Received February 25, 2011

    Report

    Report Number
    9680959-2011-00570
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    October 27, 2010
    Report Date
    February 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PROVIDED THE CUSTOMER WITH A REPAIR QUOTE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COLLIMATOR IS LOOSE, AND THE TUBE SEPARATOR AND THE DAP ION CHAMBER ARE BROKEN. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1