BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3162127 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06684
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM SHUT DOWN ON ITS OWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242860 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9600

    Patients

    Seq Age Sex Outcome Treatment
    1