BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1941170 · Received December 22, 2010

    Report

    Report Number
    9680959-2010-00605
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 22, 2010
    Manufacturer
    GE OEC MED SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. A CIRCUIT BOARD AND THE PRINTER CIRCUIT BOARD POWER LINE WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC XRAY JAA GE OEC MED SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1