BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1992819 · Received February 4, 2011

    Report

    Report Number
    9680959-2011-00258
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO PRODUCE FLUOROSCOPY X-RAY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7600

    Patients

    Seq Age Sex Outcome Treatment
    1