BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3101491 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05589
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE. THE CUSTOMER DECLINED TO HAVE THE SYSTEM REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED A HIGH CAPACITY DISK FAILURE AND LOCKED UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191592 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1