BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2043556 · Received March 28, 2011

    Report

    Report Number
    9680959-2011-00893
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE IMAGE PROCESSING COMPUTER NEEDS TO BE REPLACED. NO CONCLUSION CAN BE DRAWN SINCE THERE IS NO OTHER SERVICE INFO AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 7900 SYSTEM INTERMITTENTLY WON'T BOOT UP, AND THE LASER AIM WAS BROKEN. 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