BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2021826 · Received February 25, 2011

    Report

    Report Number
    9680959-2011-00593
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7900 SYSTEM HAD AN IMAGE PROBLEM AND THE SYSTEM IS DOWN. NO PT 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