BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3823443 · Received March 26, 2014

    Report

    Report Number
    9680959-2014-00406
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177862 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1