BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2090008 · Received April 11, 2011

    Report

    Report Number
    9680959-2011-01047
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. A FUSE WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN ON THE 7700 SYSTEM WOULD NOT TURN ON. 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 GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1