BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2960776 · Received January 30, 2013

    Report

    Report Number
    9680959-2013-00278
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM BUT THE CUSTOMER REFUSED THE REPAIR QUOTE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40072 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1