BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2153523 · Received June 21, 2011

    Report

    Report Number
    9680959-2011-01476
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE INSTRUCTED THE CUSTOMER OVER THE PHONE HOW TO REPAIR THE SYSTEM. THE SYSTEM OPERATES AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR ON THE C-ARM WOULD NOT WORK AND REQUIRED A RE-BOOT. THIS EVENT OCCURRED DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1