BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2943176 · Received January 21, 2013

    Report

    Report Number
    1720753-2013-00874
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 21, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND NOTIFIED THE CUSTOMER THE IMAGE PROCESSOR NEEDED TO BE REPLACED, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE UNUSABLE. IT COULD OR DID RESULT IN THE TERMINATION AND/OR RESCHEDULING OF AN INTERVENTIONAL PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28922 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1