BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1913637 · Received November 12, 2010

    Report

    Report Number
    9680959-2010-00484
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE KEYBOARD WAS REPAIRED AND THE CONTROL PANEL WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM'S WORKSTATION KEYBOARD FAILED TO OPERATE ALONG WITH THE CONTROL PANEL. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1